FDA product code FAG: Prosthesis, Urethral Sphincter
FAG is the FDA product code for prosthesis, urethral sphincter. It is a Class III device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FAG. The average 510(k) review took 163 days (median 163).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Urethral Sphincter |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Top FAG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Medical Systems, Inc. | 2 | 1992-03-18 |
Most recent FAG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K912934 | American Medical Systems, Inc. | AMS SPHINCTER 800 URINARY PROSTHESIS | 1992-03-18 | 257 |
| K821627 | American Medical Systems, Inc. | THE ARTIFICIAL URINARY SPHINCTER | 1982-08-10 | 69 |
Recalls for FAG devices
openFDA lists no recalls for product code FAG.
Frequently asked questions
What is FDA product code FAG?
FAG is the FDA product code for prosthesis, urethral sphincter. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is FAG?
Class III. Typical premarket route: PMA.
How long does a 510(k) take for product code FAG?
Across 2 cleared submissions the average was 163 days from receipt to decision (median 163).
Which companies have the most FAG clearances?
American Medical Systems, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code FAG
- Run a recall and safety report across every FAG manufacturer
- Watch product code FAG 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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