Data / Medical devices / Germany / Fiagon GMBH
Fiagon GMBH: FDA-registered device maker in Hennigsdorf Brandenburg, Germany, 10 510(k) clearances
Fiagon GMBH is registered with the FDA (registration 3010313588) in Hennigsdorf Brandenburg, Germany. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 2, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010313588
- Address
- Neuendorfstr. 23b, Hennigsdorf Brandenburg, Germany, 16761
- Owner or operator
- Fiagon GmbH (10046786)
- Roles
- Manufacturer
- First device listed
- May 13, 2014
- Registered through
- 2027
- Brand names listed
- Adapter for Clipsensor, Adapter for Flexsensor, Cube 4D Navigation System, Cube Navigation System, Fiagon Navigation System, FinePointer, FlexPointer, FlexPointer 1.5 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2026 | K261540 | Cube 4D Navigation System, VirtuEye Pro | PGW | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
| November 20, 2023 | K230700 | RIWOtrack Navigation System | OLO | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
| July 19, 2021 | K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | PGW | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
| March 10, 2020 | K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | PGW | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
| February 16, 2017 | K163416 | Fiagon Navigation PointerTube Straight and PointerTube Keat | PGW | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
| September 18, 2016 | K161940 | Guidewire 0.6 Single Use | PGW | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
| March 23, 2016 | K160479 | PointerShell Universal, PointerShell LS | PGW | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
| April 16, 2015 | K150473 | FlexPointer 1.5 mm | PGW | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
| October 8, 2014 | K141456 | THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL | PGW | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
| April 30, 2014 | K133573 | FIAGON NAVIGATION SYSTEM | PGW | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Ear, Nose, And Throat Stereotaxic Instrument
- All makers of Orthopedic Stereotaxic Instrument
Updated June 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.