# K023248: Lifestent LP SDS Biliary Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Orbus Medical Technologies
- Decided: Feb 11, 2003 after 134 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
54 later devices descend from it; 4 cite it directly.
0 of 55 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) PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018” 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

## 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

## Recalls of this device
- Mar 19, 2004 · Not classified · Z-1075-04: BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES.

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

Source page: https://510kreport.com/device/K023248
Methodology: https://510kreport.com/methodology