FDA.reportPublic FDA data

FlexTube 4mm

Primary DI
04260759930331
Brand
FlexTube 4mm
Company
Fiagon GmbH
Model
E012106
Catalog number
E012106
Device description
The device FlexTube 4mm is a navigation probe with suction function for image guided surgery.The device is component to the Cube4D Navigation system.
Published
2025-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGWEar, Nose, And Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141456000THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELLFiagon GmbH2014-10-08PGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260759930331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260759930331042607599303314260759930331

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose stereotactic surgery systemAn electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+13364282241support@fiagon.com

Regulatory Flags#

DUNS number
312623008
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EFIAE0135061VenSure Balloon Sinus Dilation System1E 01 35062021-06-11
EFIAE0135161VenSure Nav Balloon Sinus Dilation System12021-06-11
04260759931246VenSure Balloon Dilation System1E 01 35262022-11-10
04260759931680VenSure 4D Balloon Dilation System1E 01 35662025-09-18
04260759931260VenSure Nav Balloon Dilation System1E 01 35462022-11-10
04260759931253VenSure Light Balloon Dilation System1E 01 35362022-10-14
EFIAE0135921Vensure Inflation Device1E 01 35922022-01-21
04260759930003Integrated HeadrestE0119702025-06-25
04260759930133Navigation Unit Cube4DE011106-HD/8E011106-HD/82025-01-16
042607599301574K Navigation Unit Cube4DE011106-4K/8E011106-4K/82025-01-16
04260759930249Navigation SensorA011000A0110002025-01-16
04260759930300FlexPointerE012002E0120022025-01-16
04260759930317FlexPointer 1.5 mmE012004E0120042025-01-16
04260759930324FlexTube 3mmE012104E0121042025-01-16
04260759930348PointerTube KeatE012107E0121072025-01-16
04260759930355PointerTube KennedyE012108E0121082025-01-16
04260759930447Localizer Adhesive Pad C-TypeE012202CE012202C2025-01-16
EFIAE012202C1Localizer Adhesive padC-Type2020-03-27
EFIAE0111060Fiagon Navigation UnitCUBE4D2020-05-12
EFIAE0120021FlexPointer12016-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006427Stealth AXiSMEDTRONIC NAVIGATION, INC.PGW2026-04-24
00763000738358AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738365AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738372AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738389AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738396AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
04056481146702Curve NavigationBrainlab SEPGW2025-10-13
04260759930003Integrated HeadrestFiagon GmbHPGW2025-06-25
04260759930133Navigation Unit Cube4DFiagon GmbHPGW2025-01-16
042607599301574K Navigation Unit Cube4DFiagon GmbHPGW2025-01-16
04260759930249Navigation SensorFiagon GmbHPGW2025-01-16
04260759930300FlexPointerFiagon GmbHPGW2025-01-16
04260759930317FlexPointer 1.5 mmFiagon GmbHPGW2025-01-16
04260759930324FlexTube 3mmFiagon GmbHPGW2025-01-16
04260759930348PointerTube KeatFiagon GmbHPGW2025-01-16
04260759930355PointerTube KennedyFiagon GmbHPGW2025-01-16
04260759930447Localizer Adhesive Pad C-TypeFiagon GmbHPGW2025-01-16
04260759930515Adhesive PadFiagon GmbHPGW2024-09-02
04260759930119RegistrationPointerFiagon GmbHPGW2024-09-02
04260759930126VirtuEyeFiagon GmbHPGW2024-09-02
04260759930256Navigation Headrest UniversalFiagon GmbHPGW2024-09-02
04260759930362PointerShell 4 mm Fiagon GmbHPGW2024-09-02
04260759930379PointerShell 5 mm Fiagon GmbHPGW2024-09-02
04260759930386PointerShell 3 mm Fiagon GmbHPGW2024-09-02
04260759930393PointerShell UniversalFiagon GmbHPGW2024-09-02
14260759930512Adhesive PadFiagon GmbHPGW2024-09-02
00763000768744StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27
00763000769017StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27
00763000769123StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27
00763000769208StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27