FDA product code FAE: Prosthesis, Penile
FAE is the FDA product code for prosthesis, penile. It is a Class II device, regulated under 21 CFR 876.3630 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 32 510(k) submissions under FAE, from 11 different applicants. The average 510(k) review took 109 days (median 91). FDA has posted 3 recalls for FAE devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Penile |
| Device class | Class II |
| Regulation | 21 CFR 876.3630 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for FAE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 202 |
Compare with all 510(k) review times · Search every FAE clearance
Top FAE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Medical Systems, Inc. | 11 | 2009-04-09 |
| Dacomed Corp. | 7 | 1995-10-27 |
| Mentor Corp. | 5 | 2004-10-29 |
| Medical Engineering Corp. | 2 | 1983-10-20 |
| Boston Scientific Corporation | 1 | 2019-04-16 |
6 more applicants have FAE clearances. See the full list in Caduvo.
Most recent FAE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183619 | Boston Scientific Corporation | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device | 2019-04-16 | 111 |
| K181673 | Rigicon, Inc. | Rigi10 Malleable Penile Prosthesis | 2019-04-15 | 294 |
| K090663 | American Medical Systems, Inc. | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | 2009-04-09 | 28 |
| K082006 | American Medical Systems, Inc. | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | 2008-10-20 | 97 |
| K040959 | Mentor Corp. | MENTOR GENESIS PENILE PROSTHESIS | 2004-10-29 | 199 |
Recalls for FAE devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-04-09.
Frequently asked questions
What is FDA product code FAE?
FAE is the FDA product code for prosthesis, penile. It is a Class II device, regulated under 21 CFR 876.3630 and reviewed by the Gastroenterology and Urology panel.
What device class is FAE?
Class II, regulation 21 CFR 876.3630. Typical premarket route: 510(k).
How long does a 510(k) take for product code FAE?
Across 32 cleared submissions the average was 109 days from receipt to decision (median 91).
Which companies have the most FAE clearances?
American Medical Systems, Inc. (11); Dacomed Corp. (7); Mentor Corp. (5); Medical Engineering Corp. (2); Boston Scientific Corporation (1).
Have FAE devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2015-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code FAE
- Run a recall and safety report across every FAE manufacturer
- Watch product code FAE 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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