Cleared Special

K040667 - XPERT BILIARY STENT

K040667 is an FDA 510(k) clearance for XPERT BILIARY STENT, manufactured by Abbott Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 23-day FDA review.

K040667 · Abbott Laboratories · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
23d
Days
Class 2
Risk

K040667 is an FDA 510(k) clearance for the XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006,.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Abbott Laboratories (Redwood, US). The FDA issued a Cleared decision on April 7, 2004 after a review of 23 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K040667

510(k) Number K040667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 15, 2004
Decision Date April 07, 2004
Days to Decision 23 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
107d faster than avg
Panel avg: 130d · This submission: 23d
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 317
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K040667.
ZILVER BILIARY STENT SYSTEM USW
K040930 · Wilson-Cook Medical, Inc. · Jul 2004
WILOSN-COOK BILIARY DILATION BALLOON
K040800 · Wilson-Cook Medical, Inc. · Jun 2004
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
K040653 · Ev3, Inc. · Apr 2004
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
K040027 · Boston Scientific · Mar 2004
ZILVER 635 BILIARY STENT
K040505 · Cook, Inc. · Mar 2004
OASIS BILIARY STENT INTRODUCTION SYSTEM
K040151 · Wilson-Cook Medical, Inc. · Feb 2004