Cleared Traditional

K062996 - DISPOSABLE MONOPOLAR AND BIPOLAR STIMUL...

K062996 is an FDA 510(k) clearance for DISPOSABLE MONOPOLAR AND BIPOLAR STIMUL..., manufactured by Axon Systems, Inc.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K062996 · Axon Systems, Inc. · Neurology device
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Jan 2007
Decision
102d
Days
Class 2
Risk

K062996 is an FDA 510(k) clearance for the DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Axon Systems, Inc. (Hauppauge, US). The FDA issued a Cleared decision on January 12, 2007 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - the FDA neurology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Axon Systems, Inc. devices

FDA 510(k) Submission Details - K062996

510(k) Number K062996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date January 12, 2007
Days to Decision 102 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 148d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 - GXZ Electrode, Needle

All 15
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K062996.
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
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XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
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EEG NEEDLE ELECTRODE
K933796 · Cadwell Laboratories, Inc. · Dec 1994
CONCENTRIC EMG NEEDLE ELECTRODE
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