# K053459: Omnilink .035 Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corporation
- Decided: Apr 12, 2006 after 120 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: 5 generations back to K911292 (1991). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992319: RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System, Guidant Corp. (1999) Summary page 1.
- K011506: Omnilink .035 Biliary Stent System, Guidant Corp. (2001) Summary page 1.
- K032530: Modification to Omnilink .035 Biliary Stent System, Guidant Corporation (2003) Summary page 1.

## Indications for use
The Guidant OMNILINK® .035 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K053459
Methodology: https://510kreport.com/methodology