# K050534: Xpert Self-Expanding Transhepatic Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: May 20, 2005 after 79 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: 4 generations back to K964688 (1997). 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)
- K040667: Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008, Abbott Laboratories (2004) Summary page 1.

## Indications for use
The Xpert TM Self-Expanding Transhepatic Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Source page: https://510kreport.com/device/K050534
Methodology: https://510kreport.com/methodology