K121833 is an FDA 510(k) clearance for the OSTOMY IRRIGATION SET. This device is classified as a Irrigator, Ostomy (Class II - Special Controls, product code EXD).
Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on July 16, 2012, 24 days after receiving the submission on June 22, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5895.
| 510(k) Number | K121833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2012 |
| Decision Date | July 16, 2012 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EXD — Irrigator, Ostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5895 |