K113510 is an FDA 510(k) clearance for the EVOLUTION COLONIC STENT SYSTEM, a Stent, Colonic, Metallic, Expandable (Class II — Special Controls, product code MQR), submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on May 17, 2012, 171 days after receiving the submission on November 28, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K113510 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 28, 2011 |
| Decision Date | May 17, 2012 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MQR — Stent, Colonic, Metallic, Expandable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3610 |