Cleared Special

K040930 - ZILVER BILIARY STENT SYSTEM USW

K040930 is an FDA 510(k) clearance for ZILVER BILIARY STENT SYSTEM USW, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 84-day FDA review.

K040930 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Jul 2004
Decision
84d
Days
Class 2
Risk

K040930 is an FDA 510(k) clearance for the ZILVER BILIARY STENT SYSTEM USW. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on July 2, 2004 after a review of 84 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 Wilson-Cook Medical, Inc. devices

FDA 510(k) Submission Details - K040930

510(k) Number K040930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 09, 2004
Decision Date July 02, 2004
Days to Decision 84 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
47d faster than avg
Panel avg: 131d · This submission: 84d
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 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K040930.
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K041796 · Cordis Corporation · Aug 2004
VIABIL BILIARY ENDOPROSTHESIS
K041423 · W.L. Gore & Associates, Inc. · Jul 2004
EXTRACTOR RX RETRIEVAL BALLOON
K041606 · Boston Scientific Corp · Jul 2004
WILOSN-COOK BILIARY DILATION BALLOON
K040800 · Wilson-Cook Medical, Inc. · Jun 2004
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
K041370 · Orbus Medical Technologies · Jun 2004
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
K040653 · Ev3, Inc. · Apr 2004