# K010684: RX Herculink Plus Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Apr 12, 2001 after 35 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K053454: RX Herculink Elite Biliary Stent System (2006), 1 descendant of its own
- K063481: Modification to RX Herculink Elite Biliary Stent System (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K010684
Methodology: https://510kreport.com/methodology