Cleared Special

K030645 - BOSTON SCIENTIFIC EXPRESS BILIARY LD UN...

K030645 is the FDA 510(k) clearance for BOSTON SCIENTIFIC EXPRESS BILIARY LD UN... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 25-day FDA review.

K030645 · Boston Scientific Corp · Gastroenterology & Urology device
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Mar 2003
Decision
25d
Days
Class 2
Risk

K030645 is an FDA 510(k) clearance for the BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on March 25, 2003 after a review of 25 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 Corp devices

Submission Details

510(k) Number K030645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 28, 2003
Decision Date March 25, 2003
Days to Decision 25 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
105d faster than avg
Panel avg: 130d · This submission: 25d
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 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K030645.
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
K023666 · Rusch Intl. · Jun 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031197 · Cordis Corp. · Jun 2003
LUMINEXX ENDOSCOPIC BILIARY STENT
K031186 · C.R. Bard, Inc. · May 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
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K024048 · Boston Scientific Scimed, Inc. · Jan 2003