Fiagon GmbH
Fiagon GmbH appears in FDA public data with 0 recalls, 16 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 2, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 16
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye Pro | June 2, 2026 |
| K230700 | RIWOtrack Navigation System | November 20, 2023 |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilat | May 26, 2023 |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | July 19, 2021 |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | August 26, 2020 |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | March 10, 2020 |
| K163209 | Fiagon Navigation System | September 14, 2017 |
| K163416 | Fiagon Navigation PointerTube Straight and PointerTube Keat | February 16, 2017 |
| K162176 | Fiagon Navigation System | December 1, 2016 |
| K161940 | Guidewire 0.6 Single Use | September 18, 2016 |
| K151156 | Fiagon Navigation System | April 1, 2016 |
| K160479 | PointerShell Universal, PointerShell LS | March 23, 2016 |
| K160369 | GuideWire | March 10, 2016 |
| K150473 | FlexPointer 1.5 mm | April 16, 2015 |
| K141456 | THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, | October 8, 2014 |
| K133573 | FIAGON NAVIGATION SYSTEM | April 30, 2014 |