Cleared Special

K020682 - BARD LUMINEXX 6 FR BILIARY STENT AND DE...

K020682 is the FDA 510(k) clearance for BARD LUMINEXX 6 FR BILIARY STENT AND DE... by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 29-day FDA review.

K020682 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Apr 2002
Decision
29d
Days
Class 2
Risk

K020682 is an FDA 510(k) clearance for the BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on April 2, 2002 after a review of 29 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K020682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 04, 2002
Decision Date April 02, 2002
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
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 K020682.
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K021345 · Cordis Corp. · Jun 2002
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
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052 · Cordis Corp. · Feb 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K014184 · Guidant Corp. · Jan 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · Guidant Corp. · Jan 2002