Cleared Special

K062041 - MODEL 3875 1 X 8 SC TEST STIMULATION LEAD

K062041 is an FDA 510(k) clearance for MODEL 3875 1 X 8 SC TEST STIMULATION LEAD, manufactured by Medtronic, Inc.. The device is a Class 2 Neurology device with product code GZB cleared through the Special 510(k) pathway after a 28-day FDA review.

K062041 · Medtronic, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Aug 2006
Decision
28d
Days
Class 2
Risk

K062041 is an FDA 510(k) clearance for the MODEL 3875 1 X 8 SC TEST STIMULATION LEAD. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 16, 2006 after a review of 28 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 Medtronic, Inc. devices

FDA 510(k) Submission Details - K062041

510(k) Number K062041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2006
Decision Date August 16, 2006
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
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 116
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