# K121430: Evolution Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Mar 1, 2013 after 291 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: 10 generations back to K923119 (1992). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061231: Wellflex  Biliary RX Stent System, Boston Scientific Corp (2006) Summary page 1.
- K081733: 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890, Boston Scientific Corp (2008) Summary page 2.
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive, Boston Scientific Corp (2001) Summary page 1.
- K030107: 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM, Boston Scientific Corp (2003) Summary page 1.

## Indications for use
This device is used in palliation of malignant neoplasms in the biliary tree

Source page: https://510kreport.com/device/K121430
Methodology: https://510kreport.com/methodology