LKY · Class II · 21 CFR 876.5020

FDA Product Code LKY: Device, External Penile Rigidity

Intended To Create Or Maintain Sufficient Penile Rigidity For Sexual Intercourse. These Include Vacuum Pumps, Constriction Rings, And Penile Splints, Which Are Mechanical, Powered Or Pneumatic Devices.

Leading manufacturers include Pos-T-Vac, Inc., Ercons, Inc. and Nanma Mfg Co., Ltd..

87
Total
87
Cleared
131d
Avg days
1983
Since
87 devices
25–48 of 87
Cleared May 06, 1998
XTEND
K980752
Walling Medical Equipment Co.
Gastroenterology & Urology · 75d
Cleared Mar 11, 1998
IMPOWER EXTERNAL VACUUM SYSTEM
K980291
Imagyn Medical Technologies, Inc.
Gastroenterology & Urology · 44d
Cleared Feb 27, 1998
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE
K974082
Performance Plus, Inc.
Gastroenterology & Urology · 121d
Cleared Feb 25, 1998
ERECAID SYSTEM/STAY EREC SYSTEM
K974173
Imagyn Medical Technologies, Inc.
Gastroenterology & Urology · 112d
Cleared Feb 19, 1998
VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET
K974215
Vetco, Inc.
Gastroenterology & Urology · 101d
Cleared Jan 09, 1998
VTU-E VACUUM ERECTION SYSTEM
K974470
Encore, Inc.
Gastroenterology & Urology · 44d
Cleared Nov 03, 1997
ERCO-VAC
K972537
Ercons, Inc.
Gastroenterology & Urology · 118d
Cleared Oct 28, 1997
ERCO-RIBBON
K972353
Ercons, Inc.
Gastroenterology & Urology · 126d
Cleared Oct 16, 1997
REJOYN PENILE SUPPORT SYSTEM
K971576
American Medtech
Gastroenterology & Urology · 174d
Cleared Oct 03, 1997
VTU-1 VACUUM ERECTION SYSTEM
K971257
Mckenna & Cuneo
Gastroenterology & Urology · 182d
Cleared Sep 29, 1997
RELIANT CHARGER
K971768
Walling Medical Equipment Co.
Gastroenterology & Urology · 139d
Cleared Sep 26, 1997
RAPPORT V.T.D.
K971443
Owen Mumford USA, Inc.
Gastroenterology & Urology · 158d
Cleared Dec 10, 1996
ACTIS (VENOUS FLOW CONTROLLER)
K962915
Vivus, Inc.
Gastroenterology & Urology · 137d
Cleared Mar 08, 1996
POS-T-VAC B-10 BAND KIT
K960828
Pos-T-Vac, Inc.
Gastroenterology & Urology · 8d
Cleared Mar 01, 1996
POS-T-VAC AVP-1000 & MVP-700
K960342
Pos-T-Vac, Inc.
Gastroenterology & Urology · 37d
Cleared Feb 16, 1996
TEX-AID BLUE
K955856
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 52d
Cleared May 11, 1992
DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE
K920409
Dacomed Corp.
Gastroenterology & Urology · 101d
Cleared Dec 28, 1990
SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE
K905015
Surgitek
Gastroenterology & Urology · 51d
Cleared May 04, 1990
DACOMED NEGATIVE PRESSURE ERECTION DEVICE
K900774
Dacomed Corp.
Gastroenterology & Urology · 73d