Cleared Special

K033497 - BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM

K033497 is an FDA 510(k) clearance for BARD LUMINEXX 3 BILIARY STENT AND DELIV..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 91-day FDA review.

K033497 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
91d
Days
Class 2
Risk

K033497 is an FDA 510(k) clearance for the BARD LUMINEXX 3 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. (Tempe, US). The FDA issued a Cleared decision on February 4, 2004 after a review of 91 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K033497

510(k) Number K033497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 05, 2003
Decision Date February 04, 2004
Days to Decision 91 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
40d faster than avg
Panel avg: 131d · This submission: 91d
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 K033497.
OASIS BILIARY STENT INTRODUCTION SYSTEM
K040151 · Wilson-Cook Medical, Inc. · Feb 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
K033909 · Abbott Laboratories · Feb 2004
DURAMAX .018 BILIARY STENT SYSTEM
K032436 · Avantec Vascular Corp. · Feb 2004
OMNILINK .018 BILIARY STENT SYSTEM
K033834 · Guidant Corp. · Jan 2004
CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
K033394 · Cordis Corp. · Dec 2003
ZILVER 518 BILIARY STENT
K033348 · Cook, Inc. · Dec 2003
K033497 · BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
Download PDF FDA Summary C.R. Bard, Inc.