Definition: Transurethral Insert For Urinary Occlusion/control In Women With Urinary Incontinence
| Device Type ID | 2220 |
| Device Name | Transurethral Occlusion Insert, Urinary Incontinence-control, Female |
| Physical State | Balloon Tipped Catheter, Insertion Device |
| Technical Method | A Balloon Tipped Catheter Is Inserted Into The Urethra. Deflation Or Removal Of The Device Results In Fluid Movement |
| Target Area | Urethra |
| 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 | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OCK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2220 |
| Device | Transurethral Occlusion Insert, Urinary Incontinence-control, Female |
| Product Code | OCK |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Migration Or Expulsion Of Device | 2 |
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 3 |