The following data is part of a premarket notification filed by Cook Ireland Ltd. with the FDA for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered.
| Device ID | K163468 |
| 510k Number | K163468 |
| Device Name: | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered |
| Classification | Stent, Metallic, Expandable, Duodenal |
| Applicant | Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick, IE |
| Contact | Jacinta Kilmartin |
| Correspondent | Jacinta Kilmartin Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick, IE |
| Product Code | MUM |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-05-04 |
| Summary: | summary |