# K082093: Bullseye Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Squareone
- Decided: Jul 29, 2009 after 370 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: 2 generations back to K020682 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010411: Palmaz Genesis Transhepatic Billary Stent and Delivery System, Cordis Corp. (2001) Summary page 1.
- K033497: Bard Luminexx 3 Biliary Stent and Delivery System, C.R. Bard, Inc. (2004) Summary page 1.

## Most influential descendants
- K113582: Archstent Biliary System (2012), 0 descendants of its own

## Indications for use
BullsEye Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K082093
Methodology: https://510kreport.com/methodology