Cleared Traditional

K080037 - MODIFICATION TO ZILVER 635 BILIARY STENT

K080037 is the FDA 510(k) clearance for MODIFICATION TO ZILVER 635 BILIARY STENT by Cook, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K080037 · Cook, Inc. · Gastroenterology & Urology device
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Aug 2008
Decision
207d
Days
Class 2
Risk

K080037 is an FDA 510(k) clearance for the MODIFICATION TO ZILVER 635 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 August 1, 2008 after a review of 207 days - an extended review cycle.

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 Cook, Inc. devices

Submission Details

510(k) Number K080037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received January 07, 2008
Decision Date August 01, 2008
Days to Decision 207 days
Submission Type Traditional
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
77d slower than avg
Panel avg: 130d · This submission: 207d
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 300
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K080037.
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
K083627 · Boston Scientific Corporation · Apr 2009
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
K090133 · Cook, Inc. · Feb 2009
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
K081733 · Boston Scientific Corp · Oct 2008
BARD E LUMINEXX BILIARY STENT
K063532 · Bard Peripheral Vascular, Inc. · May 2008
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
K072301 · Ev3, Inc. · Mar 2008
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
K062798 · Cordis Corp. · Feb 2008