# K162404: Express SD Biliary Monorail Premounted Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Oct 12, 2016 after 44 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: 2 generations back to K040027 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152607: Express SD Biliary Monorail Premounted Stent System, Boston Scientific (2015) Summary page 5.

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

Source page: https://510kreport.com/device/K162404
Methodology: https://510kreport.com/methodology