# K011506: Omnilink .035 Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Jun 15, 2001 after 30 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
No predicates in its family tree.
4 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032530: Modification to Omnilink .035 Biliary Stent System (2003), 3 descendants of its own
- 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.

Source page: https://510kreport.com/device/K011506
Methodology: https://510kreport.com/methodology