# K033212: Lifestent SDS Biliary Endoprosthesis

- Pathway: 510(k) (Special)
- Applicant: Orbus Medical Technologies
- Decided: Oct 30, 2003 after 27 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 K941706 (1994). 3 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K010107: R Stent Biliary Endoprosthesis, Orbus Medical Technologies (2001)
- K941706: Opti-Plast Angioplasty Catheter, Vas-Cath, Inc. (1994) Summary page 2.
- K023308: Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary Endoprosthesis, Orbus Medical Technologies (2003) Summary page 2.
- (no number) LifeStent SDS Biliary Endoprosthesis: named in the summary without a submission number

## Most influential descendants
- 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 the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K033212
Methodology: https://510kreport.com/methodology