K971359 is an FDA 510(k) clearance for the RESTORE (A.K.A. CAPSURE). This device is classified as a External Urethral Occluder, Urinary Incontinence-control, Female (Class I - General Controls, product code MNG).
Submitted by Nebl, Inc. (Worcester, US). The FDA issued a Cleared decision on November 14, 1997, 217 days after receiving the submission on April 11, 1997.
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 | K971359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1997 |
| Decision Date | November 14, 1997 |
| Days to Decision | 217 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. |