FDA product code FTO: Prosthesis, Testicle
FTO is the FDA product code for prosthesis, testicle. It is a Class III device, regulated under 21 CFR 876.3750 and reviewed by the Gastroenterology and Urology panel. Devices under FTO reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Testicle |
| Device class | Class III |
| Regulation | 21 CFR 876.3750 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for FTO devices
openFDA lists no recalls for product code FTO.
Frequently asked questions
What is FDA product code FTO?
FTO is the FDA product code for prosthesis, testicle. It is a Class III device, regulated under 21 CFR 876.3750 and reviewed by the Gastroenterology and Urology panel.
What device class is FTO?
Class III, regulation 21 CFR 876.3750. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code FTO
- Run a recall and safety report across every FTO manufacturer
- Watch product code FTO 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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