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)
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.

View all Microprobes For Life Science, Inc. Dba Neuron devices

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
138d slower than avg
Panel avg: 148d · 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 19
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K162459.
microTargeting Guideline 4000 5.0 System
K183123 · FHC, Inc. · Dec 2018
Anchor Bolt (as an accessory to Depth Electrodes)
K181544 · Ad-Tech Medical Instrument Corporation · Aug 2018
NeuroNav System, NeuroSmart System
K172042 · Alpha Omega Engineering , Ltd. · Feb 2018
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K033730 · Pmt Corp. · Aug 2004
NEUROMAP
K981820 · Radionics, Inc. · Nov 1998
PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
K970418 · Pmt Corp. · Apr 1997