K963858 is an FDA 510(k) clearance for the FEMASSIST URINARY DEVICE. This device is classified as a External Urethral Occluder, Urinary Incontinence-control, Female (Class I - General Controls, product code MNG).
Submitted by Insight Medical Corp. (Bolton, US). The FDA issued a Cleared decision on October 21, 1997, 391 days after receiving the submission on September 25, 1996.
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 | K963858 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1996 |
| Decision Date | October 21, 1997 |
| Days to Decision | 391 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. |