K832299 is an FDA 510(k) clearance for the VISI-FLOW IRRIGATOR. This device is classified as a Irrigator, Ostomy (Class II - Special Controls, product code EXD).
Submitted by Convatec, A Division of E.R. Squibb & Sons (Walker, US). The FDA issued a Cleared decision on August 26, 1983, 44 days after receiving the submission on July 13, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5895.
| 510(k) Number | K832299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1983 |
| Decision Date | August 26, 1983 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EXD — Irrigator, Ostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5895 |