# K152607: Express SD Biliary Monorail Premounted Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Oct 27, 2015 after 46 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 K040027 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040027: Boston Scientific Express Biliary SD Premounted Stent System, Boston Scientific (2004) Summary page 5.

## Most influential descendants
- K162404: Express SD Biliary Monorail Premounted Stent System (2016), 0 descendants of its own

## 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/K152607
Methodology: https://510kreport.com/methodology