Chrysalis Intelligence · Sponsors · Fiagon GmbH

Fiagon GmbH

Hennigsdorf, DE · 6 510(k) clearances

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Total clearances
6
2020-03-10 → 2026-06-02
Last 12 months
1
Product codes
4
Most recent
2026-06-02
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PGW — — — 3 2026-06-02
OLO Orthopedic Stereotaxic Instrument Class II Neurology 1 2023-11-20
PNZ Eustachian Tube Balloon Dilation Device Class II Ear, Nose, Throat 1 2023-05-26
LRC Instrument, Ent Manual Surgical Class I Ear, Nose, Throat 1 2020-08-26
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-06-02 K261540 Cube 4D Navigation System, VirtuEye Pro PGW — —
2023-11-20 K230700 RIWOtrack Navigation System OLO Class II Neurology
2023-05-26 K230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System PNZ Class II Ear, Nose, Throat
2021-07-19 K211291 Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D PGW — —
2020-08-26 K201472 VenSure Balloon Device, VenSure Nav Balloon Device LRC Class I Ear, Nose, Throat
2020-03-10 K200041 FlexPointer 1.5 Single Use, FlexTube 3 Single Use PGW — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence