# K060624: Marathon Stent with Fusion Technology

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Aug 4, 2006 after 149 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: 2 generations back to K851962 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933200: Olympus PBD Stents, Olympus Corp. (1995) Summary page 1.
- K851962: Zimmon Biliary Stent Set, Wilson-Cook Medical, Inc. (1985) Summary page 1.
- K040151: Oasis Biliary Stent Introduction System, Wilson-Cook Medical, Inc. (2004) Summary page 1.

## Indications for use
This device is intended for endoscopic placement of a preloaded biliary stent to drain obstructed biliary ducts and reduce duodenal content reflux. This device is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K060624
Methodology: https://510kreport.com/methodology