Cleared Traditional

K162459 - AccuPoint Electrode (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162459 · Microprobes For Life Science, Inc. Dba Neuron · Neurology device
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Jun 2017
Decision
286d
Days
Class 2
Risk

K162459 is an FDA 510(k) clearance for the AccuPoint Electrode. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Microprobes For Life Science, Inc. Dba Neuron (Gaithersburg, US). The FDA issued a Cleared decision on June 15, 2017 after a review of 286 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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 Microprobes For Life Science, Inc. Dba Neuron devices

Submission Details

510(k) Number K162459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2016
Decision Date June 15, 2017
Days to Decision 286 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
138d slower than avg
Panel avg: 148d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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 - GZL Electrode, Depth

All 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K162459.
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SENSOSEEG Depth Electrodes
K213170 · Sensomedical Labs, Ltd. · Apr 2023