K954215 is an FDA 510(k) clearance for the MINIGUARD. This device is classified as a External Urethral Occluder, Urinary Incontinence-control, Female (Class I - General Controls, product code MNG).
Submitted by Advanced Surgical Intervention, Inc. (Dana Point, US). The FDA issued a Cleared decision on May 8, 1996, 243 days after receiving the submission on September 8, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 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..
| 510(k) Number | K954215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1995 |
| Decision Date | May 08, 1996 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MNG — External Urethral Occluder, Urinary Incontinence-control, Female |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5160 |
| 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. |