# K023121: Lifestent Biliary Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Orbus Medical Technologies
- Decided: Mar 10, 2003 after 172 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.
52 later devices descend from it; 1 cites it directly.
0 of 53 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) Orbus R Stent (LifeStent) Biliary Endoprosthesis: named in the summary without a submission number
- (no number) IntraTherapeutics Intrastent Biliary Endoprosthesis: named in the summary without a submission number
- (no number) IntraTherapeutics Intrastent Doublestrut Biliary Endoprosthesis: named in the summary without a submission number
- (no number) IntraTherapeutics Intrastent Doublestrut XS Biliary Endoprosthesis: named in the summary without a submission number
- (no number) Cordis Palmaz Balloon Expandable Stent: named in the summary without a submission number

## Most influential descendants
- K041370: Lifestent LP SDS Biliary Endoprosthesis (2004), 51 descendants of its own
- K050627: Lifestent Turbo Biliary Stent Systems (2005), 50 descendants of its own
- K052149: Edwards Peripheral Dilation Catheter (2005), 47 descendants of its own
- K083657: Conquest Pta Balloon Dilatation Catheter (2008), 44 descendants of its own
- K103459: Vascutrak Pta Dilatation Catheter (2010), 36 descendants of its own

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

Source page: https://510kreport.com/device/K023121
Methodology: https://510kreport.com/methodology