ClearanceBrief
Company · DE

Fiagon GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.

16510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
PGWEar, Nose, And Throat Stereotaxic Instrument11
HAWNeurological Stereotaxic Instrument2
LRCInstrument, Ent Manual Surgical1
OLOOrthopedic Stereotaxic Instrument1
PNZEustachian Tube Balloon Dilation Device1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 2, 2026K261540Cube 4D Navigation System, VirtuEye Pro
Fiagon GmbH, DE
PGW
Nov 20, 2023K230700RIWOtrack Navigation System
Fiagon GmbH, DE
OLO
May 26, 2023K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™
Fiagon GmbH, DE
PNZ
Jul 19, 2021K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
Fiagon GmbH, DE
PGW
Aug 26, 2020K201472VenSure Balloon Device, VenSure Nav Balloon Device
Fiagon GmbH, DE
LRC
Mar 10, 2020K200041FlexPointer 1.5 Single Use, FlexTube 3 Single Use
Fiagon GmbH, DE
PGW
Sep 14, 2017K163209Fiagon Navigation System
Fiagon GmbH, DE
HAW
Feb 16, 2017K163416Fiagon Navigation – PointerTube Straight and PointerTube Keat
Fiagon GmbH, DE
PGW
Dec 1, 2016K162176Fiagon Navigation System
Fiagon GmbH, DE
PGW
Sep 18, 2016K161940Guidewire 0.6 Single Use
Fiagon GmbH, DE
PGW
Apr 1, 2016K151156Fiagon Navigation System
Fiagon GmbH, DE
HAW
Mar 23, 2016K160479PointerShell Universal, PointerShell LS
Fiagon GmbH, DE
PGW
Mar 10, 2016K160369GuideWire
Fiagon GmbH, DE
PGW
Apr 16, 2015K150473FlexPointer 1.5 mm
Fiagon GmbH, DE
PGW
Oct 8, 2014K141456THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
Fiagon GmbH, DE
PGW
Apr 30, 2014K133573FIAGON NAVIGATION SYSTEM
Fiagon GmbH, DE
PGW

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
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