FAE · Class II · 21 CFR 876.3630

FDA Product Code FAE: Prosthesis, Penile

Leading manufacturers include Rigicon, Inc., Boston Scientific Corporation and C.R. Bard, Inc..

32
Total
32
Cleared
109d
Avg days
1980
Since

FDA 510(k) Cleared Prosthesis, Penile Devices (Product Code FAE)

32 devices
1–24 of 32
Cleared Apr 16, 2019
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
K183619
Boston Scientific Corporation
Gastroenterology & Urology · 111d
Cleared Apr 15, 2019
Rigi10 Malleable Penile Prosthesis
K181673
Rigicon, Inc.
Gastroenterology & Urology · 294d
Cleared Oct 24, 1986
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
K864040
C.R. Bard, Inc.
Gastroenterology & Urology · 8d

About Product Code FAE - Regulatory Context