FAEClass II

Prosthesis, Penile

21 CFR 876.3630 / Gastroenterology, Urology

FAE is the FDA product code for Prosthesis, Penile, a class II device type, regulated under 21 CFR 876.3630. As of 2026-09-10, FDA records hold 32 510(k) clearances under this code, the most recent dated 2019-04-16, and 3 recalls.

Classification record

Product code: FAE
Device name: Prosthesis, Penile
Regulation: 21 CFR 876.3630
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 32
Ingested recalls: 3

Clearances, product code FAE

By decision year

32 clearances under product code FAE with a decision year between 1980 and 2019, 1983 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code FAE by decision year
Year	Clearances
1980	1
1981	1
1982	2
1983	4
1984	3
1985	1
1986	2
1987	1
1989	1
1990	4
1991	2
1992	2
1995	2
1996	1
2004	1
2008	1
2009	1
2019	2

Applicants with the most clearances

Product code FAE

Applicants holding the most 510(k) clearances under product code FAE
Applicant	Clearances
American Medical Systems, Inc.	11
Dacomed Corp.	7
Mentor	5
Medical Engineering Corp.	2
American Medical Corp.	1
Boston Scientific Corporation	1
Burditt & Calkins-Siemens-Elema	1
C.R. Bard Inc	1
Rigicon AS	1
Ruja-Med Medical Marketing	1

Companies listing this code with FDA

Companies whose registered establishments list this code