FDA product code FJR: Forceps, Disconnect
FJR is the FDA product code for forceps, disconnect. It is a Class I device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. Devices under FJR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Disconnect |
| Device class | Class I |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for FJR devices
openFDA lists no recalls for product code FJR.
Frequently asked questions
What is FDA product code FJR?
FJR is the FDA product code for forceps, disconnect. It is a Class I device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is FJR?
Class I, regulation 21 CFR 876.5540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FJR
- Run a recall and safety report across every FJR manufacturer
- Watch product code FJR 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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