# K920218: Esophageal Z-Stent

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Feb 9, 1994 after 755 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K011591: Esophageal Z-Stent with Dua Anti-Reflux Valve (2002), 19 descendants of its own
- 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

## Recalls of this device
- Jan 30, 2003 · Not classified · Z-1410-04: Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.

Source page: https://510kreport.com/device/K920218
Methodology: https://510kreport.com/methodology