External Urethral Occluder, Urinary Incontinence-control, Female
Gastroenterology, Urology · 21 CFR 876.5160
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.
Recent MDR events
90 adverse event reports on file
- FEMSOFT URETHRAL INSERTApr 18, 2006InjuryRochester Medical Corporation2130787-2006-00001
- FEMOSOFT URETHRAL INSERTApr 11, 2003InjuryRochester Medical Corporation2130787-2003-00005
- FEMSOFT INSERTApr 11, 2003InjuryRochester Medical Corp.2130787-2003-00003
- FEMSOFT URETHRAL INSERTApr 11, 2003InjuryRochester Medical Corp.2130787-2003-00002
- FEMSOFT INSERTApr 11, 2003InjuryRochester Medical Corp.2130787-2003-00004
- FEMOSOFT INSERTAug 2, 2002InjuryRochester Medical Corporation2130787-2002-00005
- FEMSOFT INSERTAug 2, 2002InjuryRochester Medical Corporation2130787-2002-00004
- FEMSOFT URETHRAL INSERTJul 19, 2002InjuryRochester Medical Corp.2130787-2002-00003
- FEMSOFT URETHRAL INSERTJul 17, 2002InjuryRochester Medical Corporation2130787-2002-00002
- FEMSOFT INSERTApr 5, 2002InjuryRochester Medical Corporation2130787-2002-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
Huzhou Universal Glove Company Limited
Huzhou Zhejiang, CN
Hi-tech Products Inc.
Buena Park, CA, US
Sirona Hygiene Private Limited
New Delhi, IN
Guangdong Bingbing Health Care Products Ltd.
Jiangmen Guangdong, CN
Yearstar Healthcare Technology Co.,ltd
JIANGYIN Jiangsu, CN
Hi-tech Products De Mexico S.a. De C.v.
La Mesa, Tijuana Baja California, MX
510(k) clearances
7 clearances for this product code
- Personal Products Co.Apr 30, 2001
K010365 · ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
- Nebl, Inc.Mar 5, 1999
K983164 · RESTORE (AKA RE/STOR)
- Uromed Corp.Mar 31, 1998
K974600 · UROMED PATCH
- Insight Medical Corp.Feb 12, 1998
K974645 · FEMASSIST FLEXIBLE
- Nebl, Inc.Nov 14, 1997
K971359 · RESTORE (A.K.A. CAPSURE)
- Insight Medical Corp.Oct 21, 1997
K963858 · FEMASSIST URINARY DEVICE
- Advanced Surgical Intervention, Inc.May 8, 1996
K954215 · MINIGUARD