# K061235: Lifestent Turbo Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 5, 2006 after 33 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
Longest line of descent: 3 generations back to K023248 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050627: Lifestent Turbo Biliary Stent Systems, Edwards Lifesciences, LLC (2005) Summary page 1.
- K991533: Medtronic Ave Stent Delivery System - for Use in Biliary Indication, Peripheral Ave (1999) Summary page 1.

## Indications for use
The LifeStent Turbo Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Source page: https://510kreport.com/device/K061235
Methodology: https://510kreport.com/methodology