# K133110: Express LD Biliary Premounted Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jul 2, 2014 after 275 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: 8 generations back to K905720 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021630: Boston Scientific Express Biliary LD Premounted Stent System, Boston Scientific Corp (2002) Summary page 1.
- K024048: Modification to Boston Scientific Express Biliary LD Premounted Stent System, Boston Scientific Scimed, Inc. (2003) Summary page 1.
- K032360: Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express Biliary LD Unmounted Stent, Boston Scientific Corp (2003) Summary page 1.

## Indications for use
The Express LD Biliary Premounted Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K133110
Methodology: https://510kreport.com/methodology