K111365 is an FDA 510(k) clearance for the VITALA CONTINENCE CONTROL DEVICE. This device is classified as a Pouch, Colostomy (Class I - General Controls, product code EZQ).
Submitted by Convatec, Inc. (Skillman, US). The FDA issued a Cleared decision on August 19, 2011, 95 days after receiving the submission on May 16, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K111365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2011 |
| Decision Date | August 19, 2011 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZQ — Pouch, Colostomy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5900 |