# K010242: Cook Zilver Biliary Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Aug 13, 2001 after 200 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
No predicates in its family tree.
33 later devices descend from it; 2 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020788: Wilson-Cook  Zilver Biliary Stent (2002), 32 descendants of its own
- 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

Source page: https://510kreport.com/device/K010242
Methodology: https://510kreport.com/methodology