# K162717: Evolution Esophageal Stent System – Partially Covered

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Dec 21, 2016 after 83 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K920218 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080359: Evolution Esophageal Stent System, Cook Ireland, Ltd. (2008) Summary page 5.
- K093619: Evolution Esophageal Stent Fully Covered, Models Evo-FC-18-23-8-E, Evo-FC-18-23-10-E, Evo-FC-18-23-12-E, Cook Ireland, Ltd. (2010) Summary page 5.

## Indications for use
This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.

Source page: https://510kreport.com/device/K162717
Methodology: https://510kreport.com/methodology