Cleared Traditional

K163355 - Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes

K163355 is an FDA 510(k) clearance for Depth Electrodes, manufactured by Ad-Tech Medical Instrument Corporation. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K163355 · Ad-Tech Medical Instrument Corporation · Neurology device
Download Printable Device Report (PDF)
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Apr 2017
Decision
133d
Days
Class 2
Risk

K163355 is an FDA 510(k) clearance for the Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes.... Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corporation (Racine, US). The FDA issued a Cleared decision on April 12, 2017 after a review of 133 days - within the typical 510(k) review window.

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 Ad-Tech Medical Instrument Corporation devices

FDA 510(k) Submission Details - K163355

510(k) Number K163355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2016
Decision Date April 12, 2017
Days to Decision 133 days
Submission Type Traditional
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
16d faster than avg
Panel avg: 149d · This submission: 133d
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 Consultant

Quality & Regulatory Associates, LLC
Gary J Syring

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZL Electrode, Depth

All 54
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K163355.
Neuro Omega System
K171581 · Alpha Omega Engineering , Ltd. · Dec 2017
DIXI Medical Microdeep Depth Electrode
K170959 · Dixi Medical · Nov 2017
AccuPoint Electrode
K162459 · Microprobes For Life Science, Inc. Dba Neuron · Jun 2017
PMT Platinum Depthalon Depth Electrode
K151790 · Pmt Corporation · Jul 2016
DNAP Electrode
K152547 · Ad-Tech Medical Instrument Corporation · Mar 2016
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
K140680 · Alpine Biomed Aps · Dec 2014