# K041032: Modification to Lifestent SDS and XL SDS Biliary Endoprosthesis

- Pathway: 510(k) (Special)
- Applicant: Orbus Medical Technologies
- Decided: May 10, 2004 after 19 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) LifeStent SDS Biliary Endoprosthesis: named in the summary without a submission number

## Most influential descendants
- K052132: Modification to: Lifestent Valeo Biliary Stent System (2005), 0 descendants of its own

## Indications for use
The Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K041032
Methodology: https://510kreport.com/methodology