Cleared Traditional

COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM (K062264) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062264 · Medtronic Vascular · Gastroenterology & Urology device
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Nov 2007
Decision
461d
Days
Class 2
Risk

K062264 is an FDA 510(k) clearance for the COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on November 8, 2007 after a review of 461 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K062264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 04, 2006
Decision Date November 08, 2007
Days to Decision 461 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
331d slower than avg
Panel avg: 130d · This submission: 461d
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 182
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K062264.
MODIFICATION TO ZILVER 635 BILIARY STENT
K080037 · Cook, Inc. · Aug 2008
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
K062798 · Cordis Corp. · Feb 2008
RESOLVE BILIARY DRAINAGE CATHETER
K063733 · Merit Medical Systems, Inc. · Nov 2007
WELLFLEX BILIARY RX STENT SYSTEM
K061231 · Boston Scientific Corp · Sep 2006
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
K060877 · Cordis Corp. · Apr 2006
COOK FORMULA 418 BILIARY STENT SYSTEM
K052539 · Cook, Inc. · Dec 2005