FDA product code FAA: Replacer, Urethral
FAA is the FDA product code for replacer, urethral. It is a Class III device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FAA. The average 510(k) review took 42 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Replacer, Urethral |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every FAA clearance
Top FAA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Edwards Laboratories | 1 | 1983-11-29 |
Most recent FAA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833690 | American Edwards Laboratories | COAXIAL BALLOON URETHRAL DILATOR | 1983-11-29 | 42 |
Recalls for FAA devices
openFDA lists no recalls for product code FAA.
Frequently asked questions
What is FDA product code FAA?
FAA is the FDA product code for replacer, urethral. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is FAA?
Class III. Typical premarket route: PMA.
How long does a 510(k) take for product code FAA?
Across 1 cleared submissions the average was 42 days from receipt to decision (median 42).
Which companies have the most FAA clearances?
American Edwards Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FAA
- Run a recall and safety report across every FAA manufacturer
- Watch product code FAA 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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