# K941350: Wilson-Cook Gianturco-Rosch Z-Stent and Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Mar 9, 1995 after 353 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

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

## Recalls of this device
- Jan 8, 2002 · Not classified · Z-1180-03: The inner catheter of the introducer system may break after stent deployment.
- Jan 8, 2002 · Not classified · Z-1179-03: The inner catheter of the introducer system may break after stent deployment.

Source page: https://510kreport.com/device/K941350
Methodology: https://510kreport.com/methodology