# K990034: Wilson-Cook Colonic Z-Stent

- Pathway: 510(k) (Traditional)
- Applicant: Med Institute, Inc.
- Decided: Apr 17, 2000 after 467 days
- Product code: MQR (Stent, Colonic, Metallic, Expandable)
- 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
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. The FDA summary names its predicate without a number.
- (no number) Self-expandable Z-Stents manufactured by Wilson-Cook Medical, Incorporated: named in the summary without a submission number
- (no number) Self-expandable Z-Stents manufactured by Schneider (USA): named in the summary without a submission number

## 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

## Indications for use
The Wilson-Cook® Colonic Z-Stent® is a self-expanding, tubular prosthesis used to maintain patency of malignant colonic strictures in patients having high operative risk and/or advanced disease. The Wilson-Cook® Colonic Z-Stent® Introduction System is used to place the Colonic Z-Stent®. This device and the introduction system are supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K990034
Methodology: https://510kreport.com/methodology