# K080037: Modification to Zilver 635 Biliary Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Aug 1, 2008 after 207 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K163018: Zilver 635 Biliary Stent (2016), 3 descendants of its own
- 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
The Zilver® 635 TM Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K080037
Methodology: https://510kreport.com/methodology