Cleared Special

K072462 - WIDE SPACED QUATTRODE LEADS

K072462 is an FDA 510(k) clearance for WIDE SPACED QUATTRODE LEADS, manufactured by Advanced Neuromodulation Systems. The device is a Class 2 Neurology device with product code GZB cleared through the Special 510(k) pathway after a 41-day FDA review.

K072462 · Advanced Neuromodulation Systems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
41d
Days
Class 2
Risk

K072462 is an FDA 510(k) clearance for the WIDE SPACED QUATTRODE LEADS. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Advanced Neuromodulation Systems (Plano, US). The FDA issued a Cleared decision on October 11, 2007 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - the FDA neurology 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 Advanced Neuromodulation Systems devices

FDA 510(k) Submission Details - K072462

510(k) Number K072462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2007
Decision Date October 11, 2007
Days to Decision 41 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 148d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

GZB Device Classification - Class 2, Special Controls

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 Neurology devices follow this clearance model.

Regulatory Peers - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 99
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K072462.
SWIFT-LOCK ANCHOR, MODEL 1192
K092371 · Advanced Neuromodulation Systems · Dec 2009
PENTA LEAD KITS, MODELS: 3227-3234
K090907 · Advanced Neuromodulation Systems · Jun 2009
CINCH ANCHOR, MODEL 1194
K081208 · Advanced Neuromodulation Systems · Jul 2008
TRIAL CABLE, 3009
K070847 · Advanced Neuromodulation Systems · Apr 2007
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
K063080 · Advanced Neuromodulation Systems · Dec 2006
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
K062041 · Medtronic, Inc. · Aug 2006