K050483 is an FDA 510(k) clearance for the EVADRI BLADDER CONTROL SYSTEMS, a Stimulator, Electrical, Non-implantable, For Incontinence (Class II — Special Controls, product code KPI), submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on April 12, 2005, 47 days after receiving the submission on February 24, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K050483 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 2005 |
| Decision Date | April 12, 2005 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPI — Stimulator, Electrical, Non-implantable, For Incontinence |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5320 |