# K040930: Zilver Biliary Stent System Usw

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jul 2, 2004 after 84 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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 K010242 (2001). 2 ancestors in all.
24 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020788: Wilson-Cook  Zilver Biliary Stent, Wilson-Cook Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K073667: Niti-S Biliary Stent (2008), 23 descendants of its own
- K113551: Esophageal TTS Stent (2012), 10 descendants of its own
- K123205: Esophageal TTS Stent (2013), 9 descendants of its own
- K111149: Hanarostent Biliary (NNN) (2011), 6 descendants of its own
- K211706: Esophageal TTS Stent (2021), 3 descendants of its own

## Indications for use
The Wilson-Cook Zilver Biliary Stent System USE is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K040930
Methodology: https://510kreport.com/methodology