# K012090: Cordis Palmaz Genesis Transhepatic Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: Cordis, A Johnson & Johnson Co.
- Decided: Aug 1, 2001 after 27 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: 3 generations back to K905720 (1991). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 15 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.
- K991028: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories, Cordis Corp. (1999) Summary page 2.

## Most influential descendants
- K012590: Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System (2001), 5 descendants of its own
- K033909: Wavemax Balloon-Expandable Transhepatic Biliary Stent System (2004), 1 descendant of its own
- K033394: Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery System (2003), 1 descendant of its own
- K092352: Scuba Biliary Stent System (2010), 0 descendants of its own
- K041962: Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589, 20603, 20604, 20605 (2004), 0 descendants of its own

## 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/K012090
Methodology: https://510kreport.com/methodology