# K163018: Zilver 635 Biliary Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Dec 23, 2016 after 53 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). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040505: Zilver 635 Biliary Stent, Cook, Inc. (2004) Summary page 6.
- K043481: Modification to: Zilver 635 Biliary Stent, Cook, Inc. (2004) Summary page 6.
- K051124: Zilver 635 Biliary Stent, Cook, Inc. (2005) Summary page 6.
- K080037: Modification to Zilver 635 Biliary Stent, Cook, Inc. (2008) Summary page 6.
- K020788: Wilson-Cook  Zilver Biliary Stent, Wilson-Cook Medical, Inc. (2002) Summary page 6.

## Most influential descendants
- K171809: Epic Biliary Endoscopic Stent System (2017), 2 descendants of its own
- K240464: WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV (2024), 1 descendant of its own
- K242950: WallFlex Biliary PLUS RX Stent System (2024), 0 descendants of its own

## Indications for use
This device is used in palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K163018
Methodology: https://510kreport.com/methodology