# K020682: Bard Luminexx 6 FR Biliary Stent and Delivery System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 2, 2002 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
No predicates in its family tree.
17 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard® LUMINEXX™ Biliary Stent and Delivery System: named in the summary without a submission number

## Most influential descendants
- K031777: Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System (2003), 10 descendants of its own
- K033497: Bard Luminexx 3 Biliary Stent and Delivery System (2004), 9 descendants of its own
- K032457: Modification to Smart Control Nitinol Stent Transhepatic Biliary System (2003), 9 descendants of its own
- K063532: Bard E Luminexx Biliary Stent (2008), 6 descendants of its own
- K060557: Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060 (2006), 6 descendants of its own

## Indications for use
The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Source page: https://510kreport.com/device/K020682
Methodology: https://510kreport.com/methodology