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 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 Sep 09, 1980
AMS MALLEABLE OR JONAS SILICONE-SILVER
K792724
American Medical Systems, Inc.
Gastroenterology & Urology · 253d