# K010107: R Stent Biliary Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Orbus Medical Technologies
- Decided: Jul 31, 2001 after 200 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; 1 cites 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K010107
Methodology: https://510kreport.com/methodology