K863830 is an FDA 510(k) clearance for the CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM. This device is classified as a Pouch, Colostomy (Class I - General Controls, product code EZQ).
Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on October 16, 1986, 16 days after receiving the submission on September 30, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K863830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 1986 |
| Decision Date | October 16, 1986 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EZQ — Pouch, Colostomy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5900 |