# K023308: Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Orbus Medical Technologies
- Decided: Apr 14, 2003 after 193 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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) IntraStent Doublestrut ParaMount XS Biliary Endoprosthesis: named in the summary without a submission number
- (no number) PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System: named in the summary without a submission number
- (no number) OTW MEGALINK SDS Biliary Stent System: named in the summary without a submission number
- (no number) PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018” Delivery System: named in the summary without a submission number

## Most influential descendants
- K033212: Lifestent SDS Biliary Endoprosthesis (2003), 2 descendants of its own
- K040550: Lifestent SDS and XL SDS Biliary Endoprosthesis (2004), 1 descendant of its own
- K052132: Modification to: Lifestent Valeo Biliary Stent System (2005), 0 descendants of its own

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

Source page: https://510kreport.com/device/K023308
Methodology: https://510kreport.com/methodology