Cleared Traditional

K040027 - BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM

K040027 is an FDA 510(k) clearance for BOSTON SCIENTIFIC EXPRESS BILIARY SD PR..., manufactured by Boston Scientific. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K040027 · Boston Scientific · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
82d
Days
Class 2
Risk

K040027 is an FDA 510(k) clearance for the BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on March 30, 2004 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific devices

FDA 510(k) Submission Details - K040027

510(k) Number K040027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received January 08, 2004
Decision Date March 30, 2004
Days to Decision 82 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 131d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K040027.
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
K041370 · Orbus Medical Technologies · Jun 2004
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
K040653 · Ev3, Inc. · Apr 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
K040667 · Abbott Laboratories · Apr 2004
ZILVER 635 BILIARY STENT
K040505 · Cook, Inc. · Mar 2004
OASIS BILIARY STENT INTRODUCTION SYSTEM
K040151 · Wilson-Cook Medical, Inc. · Feb 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
K033909 · Abbott Laboratories · Feb 2004