# K031186: Luminexx Endoscopic Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: May 6, 2003 after 21 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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® memotherm® Endoscopic Biliary Stent: named in the summary without a submission number

## Most influential descendants
- K072720: Alimaxx-B Uncovered Biliary Stent System (2008), 1 descendant of its own
- K093947: Alimaxx-B Uncovered Biliary Stent System Endoscopic (2010), 0 descendants of its own
- K081956: Medinol X-Suit Nir Biliary Metallic Stent (2009), 0 descendants of its own

## Recalls of this device
- Mar 14, 2007 · Not classified · Z-0729-2007: Blue safety clip incorrectly placed on the stent may prevent deployment
- Mar 14, 2007 · Not classified · Z-0730-2007: Blue safety clip incorrectly placed on the stent may prevent deployment
- Jul 28, 2005 · Not classified · Z-1577-05: Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.

## Indications for use
The LUMINEXXTM Endoscopic Biliary Stent is indicated for use in the palliative treatmlent of patients with malignant biliary strictures.

Source page: https://510kreport.com/device/K031186
Methodology: https://510kreport.com/methodology