# K040151: Oasis Biliary Stent Introduction System

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Feb 20, 2004 after 28 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: 1 generation back to K851962 (1985). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 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 1.
- (no number) Wilson-Cook's OASIS Biliary Stent Introducer System: named in the summary without a submission number

## Most influential descendants
- 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 (2018), 3 descendants of its own
- 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
- K060624: Marathon Stent with Fusion Technology (2006), 0 descendants of its own

## Indications for use
The OASIS Biliary Stent Introduction System is intended for endoscopic biliary stent placement to drain obstructed bile ducts. The device is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K040151
Methodology: https://510kreport.com/methodology