FAE · Class II · 21 CFR 876.3630

FDA Product Code FAE: Prosthesis, Penile

Leading manufacturers include American Medical Systems, Inc., Mentor Corp. and Rigicon, 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 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 Jul 06, 1995
AMS 650 MALLERABLE PENIEL PROSTHESIS
K951716
American Medical Systems, Inc.
Gastroenterology & Urology · 83d
Cleared Mar 18, 1992
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
K912935
American Medical Systems, Inc.
Gastroenterology & Urology · 257d
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 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 Oct 24, 1984
MALLEABLE PENILE PROSTHESIS
K843280
Mentor Corp.
Gastroenterology & Urology · 65d
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 Aug 10, 1982
THE INFLATABLE PENILE PROSTHESIS
K821628
American Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Sep 09, 1980
AMS MALLEABLE OR JONAS SILICONE-SILVER
K792724
American Medical Systems, Inc.
Gastroenterology & Urology · 253d

About Product Code FAE - Regulatory Context