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

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 Apr 09, 2009
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K090663
American Medical Systems, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 20, 2008
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K082006
American Medical Systems, Inc.
Gastroenterology & Urology · 97d
Cleared Oct 29, 2004
MENTOR GENESIS PENILE PROSTHESIS
K040959
Mentor Corp.
Gastroenterology & Urology · 199d
Cleared Dec 04, 1996
AMS AMBICOR PENILE PROSTHESIS
K963328
American Medical Systems, Inc.
Gastroenterology & Urology · 103d
Cleared Oct 27, 1995
DUNA II PENILE PROSTHESIS
K953640
Dacomed Corp.
Gastroenterology & Urology · 84d
Cleared Jul 06, 1995
AMS 650 MALLERABLE PENIEL PROSTHESIS
K951716
American Medical Systems, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 16, 1992
DURA II PENILE PROSTHESIS
K920420
Dacomed Corp.
Gastroenterology & Urology · 76d
Cleared Mar 18, 1992
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
K912935
American Medical Systems, Inc.
Gastroenterology & Urology · 257d
Cleared Oct 11, 1991
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
K912344
Dacomed Corp.
Gastroenterology & Urology · 136d
Cleared Nov 02, 1990
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
K900371
Mentor Corp.
Gastroenterology & Urology · 280d
Cleared Jun 27, 1990
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
K901482
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 06, 1990
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
K896941
American Medical Systems, Inc.
Gastroenterology & Urology · 83d
Cleared Aug 03, 1989
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)
K890402
Mentor Corp.
Gastroenterology & Urology · 191d
Cleared Sep 18, 1987
DURAPHASE PENILE PROSTHESIS
K871653
Dacomed Corp.
Gastroenterology & Urology · 143d
Cleared Oct 24, 1986
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
K864040
C.R. Bard, Inc.
Gastroenterology & Urology · 8d
Cleared Mar 11, 1986
MENTOR CORPORAL DILATORS
K860517
Mentor Corp.
Gastroenterology & Urology · 28d
Cleared Apr 09, 1985
OMNI PHASE PENILE PROSTHESIS
K850019
Dacomed Corp.
Gastroenterology & Urology · 96d
Cleared Oct 24, 1984
MALLEABLE PENILE PROSTHESIS
K843280
Mentor Corp.
Gastroenterology & Urology · 65d
Cleared Apr 02, 1984
FLEXI-FLATE PENILE IMPLANT
K834347
Surgitek
Gastroenterology & Urology · 111d
Cleared Feb 04, 1984
ESKA JONAS SILICON-SILVER PENILE
K834504
Dacomed Corp.
Gastroenterology & Urology · 45d
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

About Product Code FAE - Regulatory Context