K090960 is an FDA 510(k) clearance for the VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,, a Catheter, Urethral (Class II — Special Controls, product code GBM), submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on August 20, 2009, 136 days after receiving the submission on April 6, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K090960 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 06, 2009 |
| Decision Date | August 20, 2009 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GBM — Catheter, Urethral |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |