# K020788: Wilson-Cook  Zilver Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: May 8, 2002 after 58 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010242 (2001). 1 ancestor in all.
32 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010242: Cook Zilver Biliary Stent, Cook, Inc. (2001) Summary page 1.

## Most influential descendants
- K040930: Zilver Biliary Stent System Usw (2004), 24 descendants of its own
- 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

## Recalls of this device
- Sep 11, 2008 · Not classified · Z-0113-2009: A section of the introduction system may detach after the stent has deployed.
- Aug 21, 2002 · Not classified · Z-0089-04: Complaints were reported of difficulty in stent deployment.
- Jan 8, 2002 · Not classified · Z-1181-03: The inner catheter of the introducer system may break after stent deployment.

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

Source page: https://510kreport.com/device/K020788
Methodology: https://510kreport.com/methodology