K862631 is an FDA 510(k) clearance for the BARD IRYFIX(TM) STOMA CAP. This device is classified as a Collector, Ostomy (Class I - General Controls, product code EXB).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on October 16, 1986, 98 days after receiving the submission on July 10, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K862631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1986 |
| Decision Date | October 16, 1986 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EXB — Collector, Ostomy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5900 |