# K182980: Zilver 518 Biliary Stent, Zilver 635 Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: Cook Ireland, Ltd.
- Decided: Nov 16, 2018 after 18 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 K033348 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163169: Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent, Cook Ireland, Ltd. (2017) Summary page 6.

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

Source page: https://510kreport.com/device/K182980
Methodology: https://510kreport.com/methodology