Cleared Special

K061566 - PRIMUS GPS BILIARY STENT SYSTEM

K061566 is the FDA 510(k) clearance for PRIMUS GPS BILIARY STENT SYSTEM by Ev3, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 86-day FDA review.

K061566 · Ev3, Inc. · Gastroenterology & Urology device
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Aug 2006
Decision
86d
Days
Class 2
Risk

K061566 is an FDA 510(k) clearance for the PRIMUS GPS BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Ev3, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 31, 2006 after a review of 86 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 Ev3, Inc. devices

Submission Details

510(k) Number K061566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received June 06, 2006
Decision Date August 31, 2006
Days to Decision 86 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
44d faster than avg
Panel avg: 130d · This submission: 86d
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 295
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K061566.
RESOLVE BILIARY DRAINAGE CATHETER
K063733 · Merit Medical Systems, Inc. · Nov 2007
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
K062264 · Medtronic Vascular · Nov 2007
WELLFLEX BILIARY RX STENT SYSTEM
K061231 · Boston Scientific Corp · Sep 2006
LIFESTENT TURBO BILIARY STENT SYSTEM
K061235 · Edwards Lifesciences, LLC · Jun 2006
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
K060877 · Cordis Corp. · Apr 2006
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
K060487 · Edwards Lifesciences, LLC · Mar 2006