MNG — External Urethral Occluder, Urinary Incontinence-Control, Female Class I
Classification Details
- Product Code
- MNG
- Device Class
- Class I
- Regulation Number
- 876.5160
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
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 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K010365 | personal products | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | April 30, 2001 |
| K983164 | nebl | RESTORE (AKA RE/STOR) | March 5, 1999 |
| K974600 | uromed | UROMED PATCH | March 31, 1998 |
| K974645 | insight medical | FEMASSIST FLEXIBLE | February 12, 1998 |
| K971359 | nebl | RESTORE (A.K.A. CAPSURE) | November 14, 1997 |
| K963858 | insight medical | FEMASSIST URINARY DEVICE | October 21, 1997 |
| K954215 | advanced surgical intervention | MINIGUARD | May 8, 1996 |