FDA product code FKF: Gun, Tie, Dialysis
FKF is the FDA product code for gun, tie, dialysis. It is a Class I device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. Devices under FKF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gun, Tie, Dialysis |
| Device class | Class I |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for FKF devices
openFDA lists no recalls for product code FKF.
Frequently asked questions
What is FDA product code FKF?
FKF is the FDA product code for gun, tie, dialysis. It is a Class I device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKF?
Class I, regulation 21 CFR 876.5820. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FKF
- Run a recall and safety report across every FKF manufacturer
- Watch product code FKF 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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