# K033394: Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Dec 22, 2003 after 60 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012590: Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System, Cordis Corp. (2001) Summary page 1.

## Most influential descendants
- K092352: Scuba Biliary Stent System (2010), 0 descendants of its own

## Recalls of this device
- May 20, 2022 · Class II · Z-1363-2022: Potential for stent dislodgement and associated failures related to two specific sizes of the device.

## Indications for use
The Cordis PALMAZ® GENESISTM Transhepatic Biliary Stent on OPTA PRO .035" Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K033394
Methodology: https://510kreport.com/methodology