# K031331: WZ Self-Expanding Stent Transhepatic Biliary System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular, Inc.
- Decided: Aug 12, 2003 after 106 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: 1 generation back to K980823 (1998). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980823: Cordis Nitinol Stent and Delivery System, Cordis Corp. (1998) Summary page 1.

## Most influential descendants
- K032929: Modification to:Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, Models 14819, 14820, 14821, 14822, 14822 (2003), 3 descendants of its own
- K050103: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System (2005), 2 descendants of its own
- K050501: Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System (2005), 1 descendant of its own
- K072708: Absolute Pro .035 Self-Expanding Stent System (2008), 0 descendants of its own

## Indications for use
The Abbott Vascular Devices XceedTMNitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K031331
Methodology: https://510kreport.com/methodology