FDA product code FAF: Prosthesis, Testicular
FAF is the FDA product code for prosthesis, testicular. It is a Class III device, regulated under 21 CFR 876.3750 and reviewed by the Gastroenterology and Urology panel. Devices under FAF reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for FAF devices.
Definition
Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Testicular |
| 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 FAF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-04-30.
Frequently asked questions
What is FDA product code FAF?
FAF is the FDA product code for prosthesis, testicular. It is a Class III device, regulated under 21 CFR 876.3750 and reviewed by the Gastroenterology and Urology panel.
What device class is FAF?
Class III, regulation 21 CFR 876.3750. Typical premarket route: PMA.
Have FAF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code FAF
- Run a recall and safety report across every FAF manufacturer
- Watch product code FAF 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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