# K050698: Modification to:Zilver 518 Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Mar 30, 2005 after 13 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 11 (0 Class I)
- 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

## Recalls of this device
- Sep 25, 2018 · Class II · Z-0316-2019: 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-0318-2019: 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-0320-2019: 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-0317-2019: 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-0321-2019: 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-0351-2019: 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-0314-2019: 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-0315-2019: 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-0319-2019: 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-0322-2019: 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-0323-2019: 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 Zilver® 518™ Biliary Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Source page: https://510kreport.com/device/K050698
Methodology: https://510kreport.com/methodology