The following data is part of a premarket notification filed by Cook Ireland Ltd. with the FDA for Evolution Esophageal Stent System – Partially Covered.
| Device ID | K162717 |
| 510k Number | K162717 |
| Device Name: | Evolution Esophageal Stent System – Partially Covered |
| Classification | Prosthesis, Esophageal |
| Applicant | Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick, IE |
| Contact | Jane Kennedy |
| Correspondent | Jane Kennedy Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick, IE |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-29 |
| Decision Date | 2016-12-21 |
| Summary: | summary |