FAE · Class II · 21 CFR 876.3630

FDA Product Code FAE: Prosthesis, Penile

Leading manufacturers include American Medical Systems, Inc., Dacomed Corp. and Mentor Corp..

32
Total
32
Cleared
109d
Avg days
1980
Since
32 devices
25–32 of 32
Cleared Oct 20, 1983
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
K832043
Medical Engineering Corp.
Gastroenterology & Urology · 118d
Cleared Aug 08, 1983
AMS MALLEABLE PENILE PROSTHESIS
K831660
American Medical Systems, Inc.
Gastroenterology & Urology · 77d
Cleared Apr 12, 1983
INFLATABLE PENILE PROSTH. - CYLINDER
K830048
American Medical Systems, Inc.
Gastroenterology & Urology · 92d
Cleared Apr 12, 1983
SURGITEK SIZER FOR PENILE PROSTHESIS
K830917
Medical Engineering Corp.
Gastroenterology & Urology · 21d
Cleared Aug 10, 1982
THE INFLATABLE PENILE PROSTHESIS
K821628
American Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Jan 25, 1982
ESKA JONAS SILICONE-SILVER PENILE PROST
K820081
Dacomed Corp.
Gastroenterology & Urology · 13d
Cleared Jan 23, 1981
ERECTAID
K803111
Burditt & Calkins-Siemens-Elema
Gastroenterology & Urology · 44d
Cleared Sep 09, 1980
AMS MALLEABLE OR JONAS SILICONE-SILVER
K792724
American Medical Systems, Inc.
Gastroenterology & Urology · 253d