Cleared Special

SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM (K030409) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030409 · Cordis Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2003
Decision
31d
Days
Class 2
Risk

K030409 is an FDA 510(k) clearance for the SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on March 10, 2003 after a review of 31 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 Cordis Corp. devices

Submission Details

510(k) Number K030409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 07, 2003
Decision Date March 10, 2003
Days to Decision 31 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
99d faster than avg
Panel avg: 130d · This submission: 31d
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 213
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K030409.
LUMINEXX ENDOSCOPIC BILIARY STENT
K031186 · C.R. Bard, Inc. · May 2003
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
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