Cleared Special

K043243 - PRIMUS STENT AND DELIVERY SYSTEM

K043243 is the FDA 510(k) clearance for PRIMUS STENT AND DELIVERY SYSTEM by Ev3, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 16-day FDA review.

K043243 · Ev3, Inc. · Gastroenterology & Urology device
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Dec 2004
Decision
16d
Days
Class 2
Risk

K043243 is an FDA 510(k) clearance for the PRIMUS STENT AND DELIVERY 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 December 9, 2004 after a review of 16 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 K043243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 23, 2004
Decision Date December 09, 2004
Days to Decision 16 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
114d faster than avg
Panel avg: 130d · This submission: 16d
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 K043243.
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050103 · Abbott Laboratories · Feb 2005
MODIFICATION TO: ZILVER 635 BILIARY STENT
K043481 · Cook, Inc. · Dec 2004
LIFESTENT NT35 BILIARY STENT SYSTEM
K042985 · Edwards Lifesciences, LLC · Dec 2004
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K042969 · Cordis Corp. · Nov 2004
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
K041962 · Abbott Laboratories · Oct 2004
ZILVER 518 BILIARY STENT
K042518 · Cook, Inc. · Oct 2004