# K010411: Palmaz Genesis Transhepatic Billary Stent and Delivery System

- Pathway: 510(k) (Abbreviated)
- Applicant: Cordis Corp.
- Decided: Aug 27, 2001 after 196 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K082093: Bullseye Biliary Stent System (2009), 1 descendant of its own
- K113582: Archstent Biliary System (2012), 0 descendants of its own

## Recalls of this device
- Sep 26, 2003 · Not classified · Z-0567-04: A packaging defect may compromise the device's sterility barrier.

Source page: https://510kreport.com/device/K010411
Methodology: https://510kreport.com/methodology