# K072720: Alimaxx-B Uncovered Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Alveolus, Inc.
- Decided: Apr 11, 2008 after 199 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002143 (2000). 16 ancestors in all.
1 later device descends from it; 1 cites 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)
- K031186: Luminexx Endoscopic Biliary Stent, C.R. Bard, Inc. (2003) Summary page 1.
- K020788: Wilson-Cook  Zilver Biliary Stent, Wilson-Cook Medical, Inc. (2002) Summary page 1.
- K033393: Absolute .035 Self-Expanding Biliary Stent System, Guidant Corp. (2003) Summary page 1.

## Most influential descendants
- K093947: Alimaxx-B Uncovered Biliary Stent System Endoscopic (2010), 0 descendants of its own

## Recalls of this device
- Jan 28, 2010 · Not classified · Z-0803-2010: Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.
- Jan 28, 2010 · Not classified · Z-0804-2010: Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.
- Jan 28, 2010 · Not classified · Z-0806-2010: Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.
- Jan 28, 2010 · Not classified · Z-0801-2010: Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.
- Jan 28, 2010 · Not classified · Z-0802-2010: Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.
- Jan 28, 2010 · Not classified · Z-0805-2010: Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.

## Indications for use
The Alveolus, ALIMAXX-B Uncovered Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K072720
Methodology: https://510kreport.com/methodology