# K040027: Boston Scientific Express Biliary SD Premounted Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Mar 30, 2004 after 82 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.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Johnson and Johnson Corinthian™ IQ Transhepatic Biliary Stent and Delivery System: named in the summary without a submission number
- (no number) Ultra-soft SV Balloon Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K152607: Express SD Biliary Monorail Premounted Stent System (2015), 1 descendant of its own
- K162404: Express SD Biliary Monorail Premounted Stent System (2016), 0 descendants of its own

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

Source page: https://510kreport.com/device/K040027
Methodology: https://510kreport.com/methodology