Modification to Boston Scientific Express Biliary Ld Premounted Stent System

by Boston Scientific Scimed, Inc.

510(k) K024048

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

510(k) K024048↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESU Special	NumberK024048	Date6 Jan 2003Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K024048
FDA Product Code: FGE

Device Class: Class II
Regulation: 21 CFR Part 876.5010
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESU

Other devices from Boston Scientific Scimed, Inc.

Niroyal Biliary Premounted Stent System

Class II
Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System

Class II
Schneider Guidezilla Softip Guiding Catheter

Class II
Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery System

Class II
Walstent Tracheobronchial Endoprosthesis

Class II
Wallstent Tracheobronchial Endoprosthesis

Class II

See all devices from Boston Scientific Scimed, Inc. →