Medical Device Manufacturer · DE , Hennigsdorf

Fiagon GmbH

15 submissions · 15 cleared · Since 2014
15
Total
15
Cleared
0
Denied

Fiagon GmbH — FDA 510(k) Submissions

Fiagon GmbH has submitted 15 FDA 510(k) premarket notifications since 2014, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ear, Nose, And Throat Stereotaxic Instrument, Neurological Stereotaxic Instrument, Instrument, Ent Manual Surgical, Eustachian Tube Balloon Dilation Device, Orthopedic Stereotaxic Instrument . Use the specialty filter in the sidebar to narrow results.

15 devices
1–12 of 15
RIWOtrack Navigation System
K230700 · OLO Orthopedic Stereotaxic... · Orthopedic
Nov 2023 252d
VenSure? Balloon Dilation System, VenSure? Light Balloon Dilation System, VenSure? Nav Balloon Dilation System, VenSure? ET Balloon Dilation System
K230065 · PNZ Eustachian Tube Balloon... · Ear, Nose, Throat
May 2023 137d
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
K211291 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Jul 2021 82d
VenSure Balloon Device, VenSure Nav Balloon Device
K201472 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Aug 2020 84d
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
K200041 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Mar 2020 62d
Fiagon Navigation System
K163209 · HAW Neurological Stereotaxic... · Neurology
Sep 2017 303d
Fiagon Navigation ? PointerTube Straight and PointerTube Keat
K163416 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Feb 2017 73d
Fiagon Navigation System
K162176 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Dec 2016 120d
Guidewire 0.6 Single Use
K161940 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Sep 2016 66d
Fiagon Navigation System
K151156 · HAW Neurological Stereotaxic... · Neurology
Apr 2016 336d
PointerShell Universal, PointerShell LS
K160479 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Mar 2016 30d
GuideWire
K160369 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Mar 2016 29d
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