# K011591: Esophageal Z-Stent with Dua Anti-Reflux Valve

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jul 19, 2002 after 421 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: 1 generation back to K920218 (1994). 2 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920218: Esophageal Z-Stent, Wilson-Cook Medical, Inc. (1994) Summary page 1.
- K990034: Wilson-Cook Colonic Z-Stent, Med Institute, Inc. (2000) Summary page 2.

## Most influential descendants
- K080782: Niti-S Esophageal Stent (2009), 15 descendants of its own
- K113551: Esophageal TTS Stent (2012), 10 descendants of its own
- K123205: Esophageal TTS Stent (2013), 9 descendants of its own
- K211706: Esophageal TTS Stent (2021), 3 descendants of its own
- K180144: Agile Esophageal Stent System (2018), 3 descendants of its own

## Indications for use
Used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistulas.

Source page: https://510kreport.com/device/K011591
Methodology: https://510kreport.com/methodology