FDA product code FKM: Adaptor, Fistula
FKM is the FDA product code for adaptor, fistula. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. Devices under FKM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Fistula |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for FKM devices
openFDA lists no recalls for product code FKM.
Frequently asked questions
What is FDA product code FKM?
FKM is the FDA product code for adaptor, fistula. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKM?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code FKM
- Run a recall and safety report across every FKM manufacturer
- Watch product code FKM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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