External Urethral Occluder, Urinary Incontinence-Control, Female
The External Urethral Occluder for Urinary Incontinence Control (Female) is a device intended to prevent or decrease episodes of urine leakage in women with stress urinary incontinence. It is applied to the urinary meatus through suction or tape to create a barrier against urine leakage, and may take the form of a cap, suction cup, or foam pad, possibly including adhesive gel or ointment. Classified as FDA Class 1, it is subject to general controls and is 510(k)-exempt. The product code is MNG, regulated under 21 CFR 876.5160 in the Gastroenterology and Urology specialty.
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Basic Information
- Product Code
- MNG
- Device Class
- FDA class 1
- Regulation Number
- 876.5160
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Apr 30, 2001 | Substantially Equivalent | Personal Products Co. |
| K983164 | RESTORE (AKA RE/STOR) | Mar 05, 1999 | Substantially Equivalent | Nebl, Inc. |
| K974600 | UROMED PATCH | Mar 31, 1998 | Substantially Equivalent | Uromed Corp. |
| K974645 | FEMASSIST FLEXIBLE | Feb 12, 1998 | Substantially Equivalent | Insight Medical Corp. |
| K971359 | RESTORE (A.K.A. CAPSURE) | Nov 14, 1997 | Substantially Equivalent | Nebl, Inc. |
| K963858 | FEMASSIST URINARY DEVICE | Oct 21, 1997 | Substantially Equivalent | Insight Medical Corp. |
| K954215 | MINIGUARD | May 08, 1996 | Substantially Equivalent | Advanced Surgical Intervention, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.