K163468 is an FDA 510(k) clearance for the Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered. This device is classified as a Stent, Metallic, Expandable, Duodenal (Class II - Special Controls, product code MUM).
Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on May 4, 2017, 143 days after receiving the submission on December 12, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K163468 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2016 |
| Decision Date | May 04, 2017 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MUM — Stent, Metallic, Expandable, Duodenal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3610 |