FDA product code FBI: Rongeur, Cystoscopic
FBI is the FDA product code for rongeur, cystoscopic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under FBI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Rongeur, Cystoscopic |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for FBI devices
openFDA lists no recalls for product code FBI.
Frequently asked questions
What is FDA product code FBI?
FBI is the FDA product code for rongeur, cystoscopic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FBI?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code FBI
- Run a recall and safety report across every FBI manufacturer
- Watch product code FBI 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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