# K172044: Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Feb 27, 2018 after 236 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). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851962: Zimmon Biliary Stent Set, Wilson-Cook Medical, Inc. (1985) Summary page 7.
- K040151: Oasis Biliary Stent Introduction System, Wilson-Cook Medical, Inc. (2004) Summary page 7.

## Most influential descendants
- K251658: Endoflux™ Biliary & Pancreatic Stent Sets (2026), 0 descendants of its own
- K230127: Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible (2023), 0 descendants of its own
- K213946: Compass BDS Biliary Stent (2022), 0 descendants of its own

## Indications for use
These devices are used to drain obstructed biliary ducts The following devices are used for endoscopic biliary stent placement: Guiding Catheter Pushing Catheter Fusion® Pushing catheter Stent Introducer Set The following devices (with preloaded stent , if applicable) are intended for endoscopic biliary stent placement to drain obstructed bile ducts: Oasis® One Action Stent Introduction System Fusion® Oasis® One Action Stent Introduction System Oasis® One Action Stent Introduction System with preloaded Cotton-Leung® Biliary stent. Oasis® One Action Stent Introduction System with preloaded ST-2 Tannenbaum® Biliary Stent.

Source page: https://510kreport.com/device/K172044
Methodology: https://510kreport.com/methodology