Cleared Special

SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K020052) - FDA 510(k) Clearance

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

K020052 · Cordis Corp. · Gastroenterology & Urology device
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Feb 2002
Decision
34d
Days
Class 2
Risk

K020052 is an FDA 510(k) clearance for the SMART NITINOL STENT TRANSHEPATIC 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 February 11, 2002 after a review of 34 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 K020052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received January 08, 2002
Decision Date February 11, 2002
Days to Decision 34 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
96d faster than avg
Panel avg: 130d · This submission: 34d
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 K020052.
WILSON-COOK ZILVER BILIARY STENT
K020788 · Wilson-Cook Medical, Inc. · May 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K020809 · Cordis Corp. · Apr 2002
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
K020682 · C.R. Bard, Inc. · Apr 2002
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · Boston Scientific Corp · Nov 2001
FANELLI BILIARY STENT
K010601 · Cook, Inc. · Nov 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752 · Boston Scientific Corp · Nov 2001