K183253 is an FDA 510(k) clearance for the ValPro 2 Plus, VaPro 2 Plus Pocket. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Hollister Incorporated (Libertyville, US). The FDA issued a Cleared decision on December 18, 2018, 27 days after receiving the submission on November 21, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K183253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2018 |
| Decision Date | December 18, 2018 |
| Days to Decision | 27 days |
| Submission Type | Special |
| 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 |