Cleared Special

K024048 - MODIFICATION TO BOSTON SCIENTIFIC EXPRE...

K024048 is the FDA 510(k) clearance for MODIFICATION TO BOSTON SCIENTIFIC EXPRE... by Boston Scientific Scimed, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 28-day FDA review.

K024048 · Boston Scientific Scimed, Inc. · Gastroenterology & Urology device
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Jan 2003
Decision
28d
Days
Class 2
Risk

K024048 is an FDA 510(k) clearance for the MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on January 6, 2003 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Scimed, Inc. devices

Submission Details

510(k) Number K024048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 09, 2002
Decision Date January 06, 2003
Days to Decision 28 days
Submission Type Special
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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 300
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K024048.
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
K030645 · Boston Scientific Corp · Mar 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
K030107 · Boston Scientific Corp · Mar 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
K030409 · Cordis Corp. · Mar 2003
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
K021994 · C.R. Bard, Inc. · Jan 2003
VIABIL BILIARY ENDOPROSTHESIS
K014215 · W.L. Gore & Associates, Inc. · Dec 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · Boston Scientific Corp · Oct 2002