# K032530: Modification to Omnilink .035 Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Guidant Corporation
- Decided: Oct 23, 2003 after 69 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: 1 generation back to K011506 (2001). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K011506: Omnilink .035 Biliary Stent System, Guidant Corp. (2001)

## Most influential descendants
- K033834: Omnilink .018 Biliary Stent System (2004), 1 descendant of its own
- K060817: Omnilink. 018 Biliary Stent System (2006), 0 descendants of its own
- K053459: Omnilink .035 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
OMNILINK@.035 Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K032530
Methodology: https://510kreport.com/methodology