FDA product code FFR: Device, Locking, For Intestinal Clamp
FFR is the FDA product code for device, locking, for intestinal clamp. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. Devices under FFR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Locking, For Intestinal Clamp |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for FFR devices
openFDA lists no recalls for product code FFR.
Frequently asked questions
What is FDA product code FFR?
FFR is the FDA product code for device, locking, for intestinal clamp. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FFR?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FFR
- Run a recall and safety report across every FFR manufacturer
- Watch product code FFR 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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