FDA product code FDJ: Snare, Rigid Self-Opening
FDJ is the FDA product code for snare, rigid self-opening. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. Devices under FDJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Snare, Rigid Self-Opening |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for FDJ devices
openFDA lists no recalls for product code FDJ.
Frequently asked questions
What is FDA product code FDJ?
FDJ is the FDA product code for snare, rigid self-opening. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is FDJ?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code FDJ
- Run a recall and safety report across every FDJ manufacturer
- Watch product code FDJ 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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