Cleared Special

K031821 - MODIFICATION TO COOK ZILVER BILIARY STENT

K031821 is the FDA 510(k) clearance for MODIFICATION TO COOK ZILVER BILIARY STENT by Cook, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 35-day FDA review.

K031821 · Cook, Inc. · Gastroenterology & Urology device
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Jul 2003
Decision
35d
Days
Class 2
Risk

K031821 is an FDA 510(k) clearance for the MODIFICATION TO COOK ZILVER BILIARY STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on July 18, 2003 after a review of 35 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 Cook, Inc. devices

Submission Details

510(k) Number K031821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received June 13, 2003
Decision Date July 18, 2003
Days to Decision 35 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
95d faster than avg
Panel avg: 130d · This submission: 35d
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 300
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K031821.
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
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031777 · Cordis Corp. · Jul 2003
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
K024303 · Edwards Lifesciences, LLC · Jul 2003
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
K023666 · Rusch Intl. · Jun 2003