# K033834: Omnilink .018 Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Jan 2, 2004 after 23 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011506 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011039: Omnilink .018 Biliary Stent System, Guidant Corp. (2001) Summary page 1.
- K032530: Modification to Omnilink .035 Biliary Stent System, Guidant Corporation (2003) Summary page 1.

## Most influential descendants
- K060817: Omnilink. 018 Biliary Stent System (2006), 0 descendants of its own

## Recalls of this device
- Aug 8, 2005 · Not classified · Z-1586-05: This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter.

## Indications for use
The ON4NILINKR® .018 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K033834
Methodology: https://510kreport.com/methodology