Cleared Traditional

K031331 - WZ SELF-EXPANDING STENT TRANSHEPATIC BI...

K031331 is the FDA 510(k) clearance for WZ SELF-EXPANDING STENT TRANSHEPATIC BI... by Abbott Vascular, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K031331 · Abbott Vascular, Inc. · Gastroenterology & Urology device
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Aug 2003
Decision
106d
Days
Class 2
Risk

K031331 is an FDA 510(k) clearance for the WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Abbott Vascular, Inc. (Redwood, US). The FDA issued a Cleared decision on August 12, 2003 after a review of 106 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Vascular, Inc. devices

Submission Details

510(k) Number K031331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 28, 2003
Decision Date August 12, 2003
Days to Decision 106 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 130d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 299
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K031331.
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032137 · Cordis Corp. · Sep 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032457 · Cordis Corp. · Sep 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT
K032360 · Boston Scientific Corp · Aug 2003
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
K032206 · Ev3, Inc. · Aug 2003
MODIFICATION TO COOK ZILVER BILIARY STENT
K031821 · Cook, Inc. · Jul 2003
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031777 · Cordis Corp. · Jul 2003