# K955728: Cordis Biliary Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: May 8, 1996 after 142 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 K885180 (1989). 9 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905720: Palmaz Biliary Stent, Johnson & Johnson Interventional Systems (1991) Summary page 1.
- K911581: Palmaz (TM) Balloon-Expandable Stent, Modification, Johnson & Johnson Interventional Systems (1991) Summary page 1.
- K885180: Expandable Biliary Stent Endoprosthesis, Schneider Intl., Ltd. (1989) Summary page 1.
- K896163: Schneider Stent Wallstent Endoscopic Biliary Endo., Schneider Stent (1989) Summary page 1.
- K911292: Schneider Wallstent (R), Pfizer Hospital Products Group, Inc. (1991) Summary page 1.
- K914277: Wallstent (R) Trans Biliary Endo W/Unistep Deliv SY, Schneider U.S. Stent Div. (1991) Summary page 1.
- K921191: Gianturco-Rosch Biliary Z Stent, Cook, Inc. (1992) Summary page 1.
- K903858: Cook-Gianturco Rosch Biliary Z-Stent, Modification, Cook, Inc. (1990) Summary page 1.
- K882610: Cook-Gianturco Biliary Z Stent, Cook, Inc. (1989) Summary page 1.

## Most influential descendants
- K980653: Perflex Stainless Steel Stent and Delivery System (1998), 7 descendants of its own
- K991929: Intrastent (1999), 3 descendants of its own
- K992319: RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System (1999), 2 descendants of its own
- K993904: Intrastent Doublestrut LD (2000), 1 descendant of its own
- K060817: Omnilink. 018 Biliary Stent System (2006), 0 descendants of its own

## Indications for use
The Cordis Biliary Stent intended use is to maintain patency of a bile duct which is obstructed from malignant neoplasms.

Source page: https://510kreport.com/device/K955728
Methodology: https://510kreport.com/methodology