# K982346: Angiodynamics Angiostent Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jan 29, 1999 after 207 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.
4 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033393: Absolute .035 Self-Expanding Biliary Stent System (2003), 3 descendants of its own
- 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
- K072708: Absolute Pro .035 Self-Expanding Stent System (2008), 0 descendants of its own

## Indications for use
The ANGIODYNAMICS ANGIOSTENT Biliary Stent System is indicated for palliative treatment of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K982346
Methodology: https://510kreport.com/methodology