# K081996: Flexstent Biliary Self Expanding Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Flexible Stenting Solutions, Inc.
- Decided: Sep 15, 2009 after 428 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Apr 23, 2013 · Class II · Z-1507-2013: Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.

## Indications for use
FlexStent® Biliary Self-Expanding Stent System is indicated for the palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K081996
Methodology: https://510kreport.com/methodology