FDA product code FTJ: Colonoscope, General & Plastic Surgery
FTJ is the FDA product code for colonoscope, general & plastic surgery. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under FTJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Colonoscope, General & Plastic Surgery |
| 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 FTJ devices
openFDA lists no recalls for product code FTJ.
Frequently asked questions
What is FDA product code FTJ?
FTJ is the FDA product code for colonoscope, general & plastic surgery. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FTJ?
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 FTJ
- Run a recall and safety report across every FTJ manufacturer
- Watch product code FTJ 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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