# K042518: Zilver 518 Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Oct 1, 2004 after 15 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K163169: Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent (2017), 1 descendant of its own
- K182980: Zilver 518 Biliary Stent, Zilver 635 Biliary Stent (2018), 0 descendants of its own

## Indications for use
The Cook Zilver® 5 1 8 TM Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K042518
Methodology: https://510kreport.com/methodology