K840268 is an FDA 510(k) clearance for the IRRIGATION SYSTEM. This device is classified as a Irrigator, Ostomy (Class II - Special Controls, product code EXD).
Submitted by Coloplast A/S (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984, 73 days after receiving the submission on January 23, 1984.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5895.
| 510(k) Number | K840268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1984 |
| Decision Date | April 05, 1984 |
| Days to Decision | 73 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 |