# K020809: Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Apr 12, 2002 after 30 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: 7 generations back to K905720 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012090: Cordis Palmaz Genesis Transhepatic Biliary Stent, Cordis, A Johnson & Johnson Co. (2001) Summary page 1.
- K012590: Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System, Cordis Corp. (2001) Summary page 2.
- K905720: Palmaz Biliary Stent, Johnson & Johnson Interventional Systems (1991) Summary page 2.
- K911581: Palmaz (TM) Balloon-Expandable Stent, Modification, Johnson & Johnson Interventional Systems (1991) Summary page 2.

## Indications for use
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K020809
Methodology: https://510kreport.com/methodology