Fiagon GmbH: FDA clearances and approvals
Fiagon GmbH has 16 FDA 510(k) clearances (first 2014, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time: 83 days. Since 2017 its median was 83 days, against 103 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 2 | 144 |
| 2015 | 1 | 52 |
| 2016 | 5 | 66 |
| 2017 | 2 | 188 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 73 |
| 2021 | 1 | 82 |
| 2022 | 0 | — |
| 2023 | 2 | 194 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 25 |
Review time against the same product codes
Since 2017, Fiagon GmbH's cleared 510(k)s took a median 83 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 11 | 11 |
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| LRC | Instrument, Ent Manual Surgical | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| PNZ | Eustachian Tube Balloon Dilation Device | 1 | 1 |
Review panels
- Ear, Nose and Throat (13)
- Neurology (2)
- Orthopedic (1)
Most recent Fiagon GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye Pro | PGW | 2026-06-02 | 25 |
| K230700 | RIWOtrack Navigation System | OLO | 2023-11-20 | 252 |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System | PNZ | 2023-05-26 | 137 |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | PGW | 2021-07-19 | 82 |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | LRC | 2020-08-26 | 84 |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | PGW | 2020-03-10 | 62 |
| K163209 | Fiagon Navigation System | HAW | 2017-09-14 | 303 |
| K163416 | Fiagon Navigation PointerTube Straight and PointerTube Keat | PGW | 2017-02-16 | 73 |
| K162176 | Fiagon Navigation System | PGW | 2016-12-01 | 120 |
| K161940 | Guidewire 0.6 Single Use | PGW | 2016-09-18 | 66 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fiagon GmbH.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Fiagon GmbH have?
Fiagon GmbH has 16 FDA 510(k) clearances (first 2014, latest 2026), across 5 product codes in 3 review panels.
How long does FDA take to clear Fiagon GmbH's 510(k)s?
The median time from FDA receipt to decision across Fiagon GmbH's cleared 510(k)s is 83 days. Since 2017: 83 days, versus 103 days for all cleared 510(k)s in the same product codes.
What devices does Fiagon GmbH make?
Its most frequent FDA product codes are PGW (Ear, Nose, And Throat Stereotaxic Instrument, 11); HAW (Neurological Stereotaxic Instrument, 2); LRC (Instrument, Ent Manual Surgical, 1).
Has Fiagon GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Fiagon GmbH. Related entities may recall under other names.
Next steps
- See all 16 Fiagon GmbH clearances with predicates and recalls
- Run predicate analysis for product code PGW, Fiagon GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.