# K052539: Cook Formula 418 Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Dec 9, 2005 after 85 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: 4 generations back to K983008 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051785: Formula 418 Biliary Stent, Cook, Inc. (2005) Summary page 1.
- K011817: Bridge FX, Medtronic Ave, Inc. (2001) Summary page 1.
- K021345: Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System, Cordis Corp. (2002) Summary page 1.
- K023248: Lifestent LP SDS Biliary Endoprosthesis, Orbus Medical Technologies (2003) Summary page 1.

## Indications for use
The Cook® Formula 418™ Biliary Stent System is indicated for use in palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K052539
Methodology: https://510kreport.com/methodology