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 Foa
| Device Type ID | 1998 |
| Device Name | External Urethral Occluder, Urinary Incontinence-control, Female |
| Physical State | Occluding Device Such As A Cap, Suction Cup, Or Foam Pad. May Include Adhesive Gel Or Ointment. |
| Technical Method | Occluder Is Applied To Urinary Meatus Through Suction Or Tape, Which Creates A Barrier For Urine Leakage. |
| Target Area | Female Urinary Meatus |
| Regulation Description | Urological Clamp For Males. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.5160 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MNG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1998 |
| Device | External Urethral Occluder, Urinary Incontinence-control, Female |
| Product Code | MNG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urological Clamp For Males. |
| CFR Regulation Number | 876.5160 [🔎] |