# K041370: Lifestent LP SDS Biliary Endoprosthesis

- Pathway: 510(k) (Special)
- Applicant: Orbus Medical Technologies
- Decided: Jun 24, 2004 after 31 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: 1 generation back to K023248 (2003). 2 ancestors in all.
51 later devices descend from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023121: Lifestent Biliary Endoprosthesis, Orbus Medical Technologies (2003) Summary page 2.
- K023248: Lifestent LP SDS Biliary Endoprosthesis, Orbus Medical Technologies (2003) Summary page 2.

## Most influential descendants
- 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
- K112182: Angiosculpt Pta Scoring Balloon Catheter (2011), 29 descendants of its own

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

Source page: https://510kreport.com/device/K041370
Methodology: https://510kreport.com/methodology