# K043481: Modification to: Zilver 635 Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Dec 29, 2004 after 14 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 28 (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 25, 2018 · Class II · Z-0327-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0329-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0339-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0325-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0336-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0338-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0345-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0346-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0348-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0349-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0350-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0326-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0330-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0334-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0341-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0342-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0352-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0324-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0328-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0331-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0332-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0333-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0335-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0337-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0340-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0343-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0344-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Sep 25, 2018 · Class II · Z-0347-2019: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.

## 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/K043481
Methodology: https://510kreport.com/methodology