FDA product code FBJ: Cord, Electric For Transurethral Surgical Instrument
FBJ is the FDA product code for cord, electric for transurethral surgical instrument. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. Devices under FBJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Cord, Electric For Transurethral Surgical Instrument |
| 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 FBJ devices
openFDA lists no recalls for product code FBJ.
Frequently asked questions
What is FDA product code FBJ?
FBJ is the FDA product code for cord, electric for transurethral surgical instrument. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is FBJ?
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 FBJ
- Run a recall and safety report across every FBJ manufacturer
- Watch product code FBJ 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.
All Gastroenterology and Urology product codes · FDA product code lookup