# Fiagon GmbH

- Location (FDA's records): Hennigsdorf, DE
- FDA decisions: 16 (2014–2026): 16 510(k) clearances
- Product codes: PGW (11), HAW (2), OLO (1), LRC (1), PNZ (1)
- 510(k) review time since 2016: median 79 days, against 115 for FDA's reviews in the same codes and years (8 of 12 faster)
- Predicates its devices cite: 29 (14 its own); citations of its devices by later devices: 23 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Navigation, Inc.: 4 (https://510kreport.com/company/medtronic-navigation)
- Visualization Technology, Inc.: 3 (https://510kreport.com/company/visualization-technology)
- Entellus Medical, Inc.: 2 (https://510kreport.com/company/entellus-medical)
- Joimax GmbH: 1 (https://510kreport.com/company/joimax)
- Medtronic Xomed, Inc.: 1 (https://510kreport.com/company/medtronic-xomed)
- Synaptive Medical, Inc.: 1 (https://510kreport.com/company/synaptive-medical)
- Medtronic Surgical Navigation Technologies: 1 (https://510kreport.com/company/medtronic-surgical-navigation-technologies)
- Compass Intl., Inc.: 1 (https://510kreport.com/company/compass-intl)

## Firms that cite its devices most
- Biosense Webster, Inc.: 2 (https://510kreport.com/company/biosense-webster)
- Acclarent, Inc.: 2 (https://510kreport.com/company/acclarent)
- Scopis GmbH: 2 (https://510kreport.com/company/scopis)
- Stryker Ent: 2 (https://510kreport.com/company/stryker-ent)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)

## Its most-cited devices
- K133573: Fiagon Navigation System (2014), cited by 8
- K141456: The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell (2014), cited by 6
- K162176: Fiagon Navigation System (2016), cited by 2
- K150473: FlexPointer 1.5 mm (2015), cited by 2
- K201472: VenSure Balloon Device, VenSure Nav Balloon Device (2020), cited by 1
- K151156: Fiagon Navigation System (2016), cited by 1

## Recent decisions
- K261540: Cube 4D Navigation System, VirtuEye Pro (Jun 2, 2026)
- K230700: RIWOtrack Navigation System (Nov 20, 2023)
- K230065: VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (May 26, 2023)
- K211291: Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D (Jul 19, 2021)
- K201472: VenSure Balloon Device, VenSure Nav Balloon Device (Aug 26, 2020)
- K200041: FlexPointer 1.5 Single Use, FlexTube 3 Single Use (Mar 10, 2020)
- K163209: Fiagon Navigation System (Sep 14, 2017)
- K163416: Fiagon Navigation – PointerTube Straight and PointerTube Keat (Feb 16, 2017)

Source page: https://510kreport.com/company/fiagon