FDA Product Code MNG: External Urethral Occluder, Urinary Incontinence-control, Female
Intended To Prevent Or Decrease Episodes Of Urine Leakage In Women With Stress Incontinence. Occluder Is Applied To Urinary Meatus Through Suction Or Tape, Which Creates A Barrier For Urine Leakage. Occluding Device Such As A Cap, Suction Cup, Or Foam Pad. May Include Adhesive Gel Or Ointment.
Leading manufacturers include Insight Medical Corp., Nebl, Inc. and Personal Products Co..
7
Total
7
Cleared
183d
Avg days
1996
Since
FDA 510(k) Cleared External Urethral Occluder, Urinary Incontinence-control, Female Devices (Product Code MNG)
7 devices
Cleared
Apr 30, 2001
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
Personal Products Co.
Gastroenterology & Urology
82d
Cleared
Mar 05, 1999
RESTORE (AKA RE/STOR)
Nebl, Inc.
Gastroenterology & Urology
176d
Cleared
Mar 31, 1998
UROMED PATCH
Uromed Corp.
Gastroenterology & Urology
112d
Cleared
Feb 12, 1998
FEMASSIST FLEXIBLE
Insight Medical Corp.
Gastroenterology & Urology
62d
Cleared
Nov 14, 1997
RESTORE (A.K.A. CAPSURE)
Nebl, Inc.
Gastroenterology & Urology
217d
Cleared
Oct 21, 1997
FEMASSIST URINARY DEVICE
Insight Medical Corp.
Gastroenterology & Urology
391d
Cleared
May 08, 1996
MINIGUARD
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology
243d