# K063481: Modification to RX Herculink Elite Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular, Inc.
- Decided: Sep 14, 2007 after 301 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: 8 generations back to K905720 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053454: RX Herculink Elite Biliary Stent System, Guidant Corporation (2006) Summary page 1.
- K010684: RX Herculink Plus Biliary Stent System, Guidant Corp. (2001) Summary page 1.

## Indications for use
The RX Herculink®Elite™ Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K063481
Methodology: https://510kreport.com/methodology