# K051124: Zilver 635 Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Jul 12, 2005 after 70 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K163169: Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent (2017), 1 descendant of its own
- K242950: WallFlex Biliary PLUS RX Stent System (2024), 0 descendants of its own

## Recalls of this device
- Sep 21, 2006 · Not classified · Z-0080-2007: The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40)
- Jan 26, 2006 · Not classified · Z-0600-06: The side of the boxes give incorrect sizes for these stents. The label front is correct.
- Oct 24, 2005 · Not classified · Z-0391-06: The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. The label front is correct.
- Oct 24, 2005 · Not classified · Z-0390-06: The side of the box gives the size of the stent as 10 x 40 instead of the actual size of 7 x 40. The label front is correct.

## Indications for use
The Cook® Zilver® 635 TM Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K051124
Methodology: https://510kreport.com/methodology