Cleared Special

K030645 - BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT

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

K030645 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K030645

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
106d faster than avg
Panel avg: 131d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 477
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K030645.
PANCREATIC DRAINAGE TUBE
K021672 · Aomori Olympus Co., Ltd. · Apr 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
K023308 · Orbus Medical Technologies · Apr 2003
JOSTENT SELFX, MODELS 015SX4406
K030053 · Jomed AG · Mar 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
K030107 · Boston Scientific Corp · Mar 2003
LIFESTENT BILIARY ENDOPROSTHESIS
K023121 · Orbus Medical Technologies · Mar 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
K030409 · Cordis Corp. · Mar 2003
K030645 · BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
Download PDF FDA Summary Boston Scientific Corp