Cleared Traditional

K162459 - AccuPoint Electrode

K162459 is an FDA 510(k) clearance for AccuPoint Electrode, manufactured by Microprobes For Life Science, Inc. Dba Neuron. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K162459 · Microprobes For Life Science, Inc. Dba Neuron · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K162459

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
137d slower than avg
Panel avg: 149d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

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.
NeuroNav System, NeuroSmart System
K172042 · Alpha Omega Engineering , Ltd. · Feb 2018
Neuro Omega System
K171581 · Alpha Omega Engineering , Ltd. · Dec 2017
DIXI Medical Microdeep Depth Electrode
K170959 · Dixi Medical · Nov 2017
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
K163355 · Ad-Tech Medical Instrument Corporation · Apr 2017
PMT Platinum Depthalon Depth Electrode
K151790 · Pmt Corporation · Jul 2016
DNAP Electrode
K152547 · Ad-Tech Medical Instrument Corporation · Mar 2016
K162459 · AccuPoint Electrode
Download PDF FDA Summary Microprobes For Life …