K052229 is an FDA 510(k) clearance for the COLOPLAST OSTOMY ROD, MODEL 12814, a Rod, Colostomy (Class II — Special Controls, product code EZP), submitted by Coloplast Corp. (North Mankato, US). The FDA issued a Cleared decision on October 13, 2006, 423 days after receiving the submission on August 16, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4270.
| 510(k) Number | K052229 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 2005 |
| Decision Date | October 13, 2006 |
| Days to Decision | 423 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZP — Rod, Colostomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4270 |