# K080359: Evolution Esophageal Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: May 9, 2008 after 88 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: 2 generations back to K920218 (1994). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011591: Esophageal Z-Stent with Dua Anti-Reflux Valve, Wilson-Cook Medical, Inc. (2002)
- K940395: Wallstent Esophageal Prosthesis, Boston Scientific Scimed, Inc. (1994) Summary page 1.
- K032930: Ultraflex Esophageal NG Stent System, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- 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 (2010), 1 descendant of its own
- K162717: Evolution Esophageal Stent System – Partially Covered (2016), 0 descendants of its own

## 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/K080359
Methodology: https://510kreport.com/methodology