# K012087: Cordis Palmaz Genesis Transhepatic Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Aug 1, 2001 after 29 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: 5 generations back to K905720 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001258: BX Transhepatic Biliary Stent and Delivery System, Cordis Corp. (2000) Summary page 1.
- K992755: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis Introducer Tube, Cordis, A Johnson & Johnson Co. (1999) Summary page 2.
- K994156: Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B, PQ394B, Cordis Corp. (2000) 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/K012087
Methodology: https://510kreport.com/methodology