fiagon.comRIWOtrack Navigation System
Fiagon GmbH
Fiagon GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010313588 | 3010313588 | Fiagon GMBH | 1 | N | 2026-01-01 | Neuendorfstr. 23b Hennigsdorf Brandenburg DE 16761 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04260759930003 | Integrated Headrest - The Integrated Headrest is mounted on the procedure chairs. It comprises a holder for a Navigation sensor, which creates an electromagnetic field above the cushion of the Integrated Headrest. The Integrated Headrest comes with the following adapters: 1) Chair Adapter 4020 2) Chair Adapter 2512. | 13364282241 | support@fiagon.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 171354 | 1531443403 | K261540 | Cube 4D Navigation System, VirtuEye Pro | PGW | 2026-06-02 |
| 171354 | 1702211551 | K230700 | RIWOtrack Navigation System | OLO | 2023-11-20 |
| 171354 | 1830886858 | K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System | PNZ | 2023-05-26 |
| 171354 | 1524698845 | K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | PGW | 2021-07-19 |
| 171354 | 1707489955 | K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | LRC | 2020-08-26 |
| 171354 | 1236421636 | K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | PGW | 2020-03-10 |
| 171354 | 1117062388 | K163416 | Fiagon Navigation – PointerTube Straight and PointerTube Keat | PGW | 2017-02-16 |
| 171354 | 1595423212 | K163209 | Fiagon Navigation System | HAW | 2017-09-14 |
| 171354 | 2009641097 | K162176 | Fiagon Navigation System | PGW | 2016-12-01 |
| 171354 | 1249902926 | K161940 | Guidewire 0.6 Single Use | PGW | 2016-09-18 |
| 171354 | 1864809421 | K160479 | PointerShell Universal, PointerShell LS | PGW | 2016-03-23 |
| 171354 | 1862384421 | K160369 | GuideWire | PGW | 2016-03-10 |
| 171354 | 1813860999 | K151156 | Fiagon Navigation System | HAW | 2016-04-01 |
| 171354 | 1165589680 | K150473 | FlexPointer 1.5 mm | PGW | 2015-04-16 |
| 171354 | 1456250866 | K141456 | THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL | PGW | 2014-10-08 |
| 171354 | 1767512797 | K133573 | FIAGON NAVIGATION SYSTEM | PGW | 2014-04-30 |
Product Codes Associated With Registrations#
PMN#
VenSure? Balloon Dilation System, VenSure? Light Balloon Dilation System, VenSure? Nav Balloon Dilation System, VenSure? ET Balloon Dilation System
Fiagon GmbH
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
Fiagon GmbH
VenSure Balloon Device, VenSure Nav Balloon Device
Fiagon GmbH
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
Fiagon GmbH
Fiagon Navigation System
FIAGON GMBH
Fiagon Navigation – PointerTube Straight And PointerTube Keat
FIAGON GMBH
Fiagon Navigation System
Fiagon GmbH
Fiagon Navigation System
FIAGON GMBH
PointerShell Universal, PointerShell LS
FIAGON GMBH
GuideWire
FIAGON GMBH
FlexPointer 1.5 Mm
FIAGON GMBH
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
FIAGON GMBH
FIAGON NAVIGATION SYSTEM
FIAGON GMBH
GUDID#
VenSure Balloon Sinus Dilation System - 1
2021-06-11
VenSure Nav Balloon Sinus Dilation System - 1
2021-06-11
VenSure Balloon Dilation System - Balloon Dilation system as set including Balloon dilation device with bending tool and Inflation device with tubes,
2022-11-10
VenSure 4D Balloon Dilation System - Balloon Dilation system as a set including navigated Balloon dilation device with bending tool and inflation device tubes.
2025-09-18
VenSure Nav Balloon Dilation System - Balloon Dilation system as set including navigated Balloon dilation device with bending tool and Inflation device with tubes,
2022-11-10
VenSure Light Balloon Dilation System - Balloon Dilation system as set including Balloon dilation device, Inflation device with tubes, light-confirmation device
2022-10-14
Vensure Inflation Device - Inflation device for Vensure Balloon Dilation System
2022-01-21
Integrated Headrest - The Integrated Headrest is mounted on the procedure chairs. It comprises a holder for a Navigation sensor, which creates an electromagnetic field above the cushion of the Integrated Headrest. The Integrated Headrest comes with the following adapters: 1) Chair Adapter 4020 2) Chair Adapter 2512.
2025-06-25
Navigation Unit Cube4D - Navigation unit, Component of Cube4D Navigation System
2025-01-16
4K Navigation Unit Cube4D - Navigation unit 4K, Component of Cube4D Navigation System
2025-01-16
Navigation Sensor - Field generating device of electromagnetic navigation system Cube4D (image guided surgery).The device is component of the Cube4D Navigation system.
2025-01-16
FlexPointer - The device FlexPointer is a navigation probe for image guided surgery.The device is component to the Cube4D Navigation system.
2025-01-16
FlexPointer 1.5 mm - The device FlexPointer 1.5 mmis a navigation probe for image guided surgery.The device is component to the Cube4D Navigation system.
2025-01-16
FlexTube 3mm - The device FlexTube 3mm is a navigation probe with suction function for image guided surgery.The device is component to the Cube4D Navigation system.
2025-01-16
FlexTube 4mm - The device FlexTube 4mm is a navigation probe with suction function for image guided surgery.The device is component to the Cube4D Navigation system.
2025-01-16
PointerTube Keat - The device PointerTube Keat is a navigation probe with suction function for image guided surgery.The device is component to the Cube4D Navigation system.
2025-01-16
PointerTube Kennedy - The device PointerTube Kennedy is a navigation probe with suction function for image guided surgery.The device is component to the Cube4D Navigation system.
2025-01-16
Localizer Adhesive Pad C-Type - The device localizer Adhesive Pad C-Type is patient reference device for image guided surgery. The device is component of the Cube4D Navigation System.
2025-01-16
Localizer Adhesive pad - The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use ofthe navigation system describe the proper use of the entire system in detail.The adhesive pad is an accessory of the Localizer Adhesive pad.The model C-Type has a modified plug.
2020-03-27
Fiagon Navigation Unit - The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device is 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, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomyThis also comprises of accessories 1) Extension cable instrument 2) Multi Instrument support3) FootSwitch 4) PC mouse 5) Service Keyboard 6)DVI monitor cable 7) VGA monitor cable 8) Monitor cable control 9) HDMI monitor cable 10) SDI video Cable 11) Power Cable (US)
2020-05-12
FlexPointer - The product FlexPointer are product variants of a navigated pointer probe forimage guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. 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 orMR based model of the anatomy.
2016-08-05
FlexPointer 1.5 - The product FlexPointer 1.5 are product variants of a navigatedpointer probe for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. 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 orMR based model of the anatomy.
2016-08-09
FlexTube 3mm - The products are variants of a navigated suction instrument for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. 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 orMR based model of the anatomy.
2016-08-08
FlexTube 4 mm - The products are variants of a navigated suction instrument for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. 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 orMR based model of the anatomy.
2016-08-08
PointerTube Keat - The product is a variant of a navigated suction instrument for image guided surgical procedures .The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument is indicated for any medical condition in which the use ofstereotactic 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.
2017-11-21
PointerTube Kennedy - The product is a variant of a navigated suction instrument for image guided surgical procedures .The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument is indicated for any medical condition in which the use ofstereotactic 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.
2017-11-21
Adhesive Pad - 1
2022-01-21
Adhesive Pad - Adhesive pads for fixation of patient localizer for image guided surgery.The device is accessory to the Cube 4D Navigation system.
2024-09-02
RegistrationPointer - The device RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The device is accessory to the Cube 4D Navigation system.
2024-09-02
VirtuEye - The device VirtuEye is a device for non-tactile registration for image guided surgical procedures. The device is accessory to the Cube 4D Navigation system.
2024-09-02
Navigation Headrest Universal - Headrest for navigation. Navigation sensor support for image guided surgery.The device is accessory to the Cube 4D Navigation system.
2024-09-02
PointerShell 4 mm - The device PointerShell 4mm is an instrument tracker adapter for image guided surgery for instruments shafts of 3.5mm to 4mm.The device is accessory to the Cube 4D Navigation system.
2024-09-02
PointerShell 5 mm - The device PointerShell 5mm is an instrument tracker adapter for image guided surgery for instruments shafts of 4.7mm to 5mm.The device is accessory to the Cube 4D Navigation system.
2024-09-02
PointerShell 3 mm - The device PointerShell 3mm is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 3.4mm.The device is accessory to the Cube 4D Navigation system.
2024-09-02
PointerShell Universal - The device PointerShell Universal is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 5mm.The device is accessory to the Cube 4D Navigation system.
2024-09-02
Adhesive Pad - Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation system.
2024-09-02
VirtuEye - Accessory to Cube navigation systems. Device for registration.
2022-01-10
Navigation Headrest Universal - The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, whichcreates an electromagnetic field above the cushion of the Navigation headrest.The navigation headrest Universal comes with the following adapters:1) Adapters for siderails2)Adapters for Mizuho/Skytron Tables3)Adapters for Maquet Tables4)Adapters for Steris table5)Adapters for Eschmann Tables6)Flexarm adapters for for navigation sensor
2016-08-05
Guidewire 0.6 Single Use - The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image guided surgical procedures with the XprESSLoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool.The instrument is an accessory to the Fiagon navigation system. It is designed to be used with the FiagonNavigation system and with XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool.The XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool are produced by EntellusMedical Inc./USA and are registered as 510K devices with the FDA. These are not subject of this instructions foruse.
2017-11-23
RegistrationPointer - The products RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guidedsurgical procedures. The instrument is part of the Fiagon Navigation – Extended instrument set ENT, which isdesigned to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigationsystem produced by Fiagon GmbH.The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system usingelectromagnetic navigation.The Fiagon Navigation – Extended Instrument Set ENT is indicated for any medical condition in which the use ofstereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENTsurgery can be identified relative to a CT or MR based model of the anatomy.
2016-08-08