K010365 is an FDA 510(k) clearance for the ORTHO CONTROL FEMALE URINARY CONTROL DEVICE, a External Urethral Occluder, Urinary Incontinence-control, Female (Class I — General Controls, product code MNG), submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on April 30, 2001, 82 days after receiving the submission on February 7, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5160.
| 510(k) Number | K010365 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 07, 2001 |
| Decision Date | April 30, 2001 |
| Days to Decision | 82 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. |