# K163169: Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Feb 7, 2017 after 85 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: 1 generation back to K033348 (2003). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033348: Zilver 518 Biliary Stent, Cook, Inc. (2003) Summary page 6.
- K042518: Zilver 518 Biliary Stent, Cook, Inc. (2004) Summary page 6.
- K050698: Modification to:Zilver 518 Biliary Stent, Cook, Inc. (2005) Summary page 6.
- 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.

## Most influential descendants
- K182980: Zilver 518 Biliary Stent, Zilver 635 Biliary Stent (2018), 0 descendants of its own

## Indications for use
The Zilver 518 and 635 Biliary Stent are indicated for use in palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K163169
Methodology: https://510kreport.com/methodology