FlexTube 4 mm

GUDID EFIAE0121061

The products are variants of a navigated suction instrument for image guided surgical procedures The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.

Fiagon GmbH

Multi-purpose stereotactic surgery system

• Primary Device ID: EFIAE0121061
• NIH Device Record Key: 3191fc23-a54b-4516-87a6-ed06b26244f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexTube 4 mm
• Version Model Number: 1
• Company DUNS: 312623008
• Company Name: Fiagon GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EFIAE0121060 [Direct Marking]
HIBCC	EFIAE0121061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141456

FDA Product Code

• PGW: Ear, Nose, And Throat Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

[EFIAE0121061]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-30
• Device Publish Date: 2016-08-08

Devices Manufactured by Fiagon GmbH

• 04260759930119 - RegistrationPointer: 2024-09-10 The device RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical pro
• 04260759930126 - VirtuEye: 2024-09-10 The device VirtuEye is a device for non-tactile registration for image guided surgical procedures. The device is accessory to t
• 04260759930256 - Navigation Headrest Universal: 2024-09-10 Headrest for navigation. Navigation sensor support for image guided surgery. The device is accessory to the Cube 4D Navigation s
• 04260759930362 - PointerShell 4 mm: 2024-09-10 The device PointerShell 4mm is an instrument tracker adapter for image guided surgery for instruments shafts of 3.5mm to 4mm. Th
• 04260759930379 - PointerShell 5 mm: 2024-09-10 The device PointerShell 5mm is an instrument tracker adapter for image guided surgery for instruments shafts of 4.7mm to 5mm. Th
• 04260759930386 - PointerShell 3 mm: 2024-09-10 The device PointerShell 3mm is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 3.4mm.
• 04260759930393 - PointerShell Universal: 2024-09-10 The device PointerShell Universal is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 5
• 14260759930512 - Adhesive Pad: 2024-09-10 Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation syst