# K040550: Lifestent SDS and XL SDS Biliary Endoprosthesis

- Pathway: 510(k) (Special)
- Applicant: Orbus Medical Technologies
- Decided: Mar 16, 2004 after 14 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: 2 generations back to K941706 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023308: Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary Endoprosthesis, Orbus Medical Technologies (2003) Summary page 2.
- K033212: Lifestent SDS Biliary Endoprosthesis, Orbus Medical Technologies (2003) Summary page 2.

## 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/K040550
Methodology: https://510kreport.com/methodology