Cleared Traditional

K183437 - AirRay Subdural Cortical Electrodes

K183437 is the FDA 510(k) clearance for AirRay Subdural Cortical Electrodes by Cortec GmbH. It is a Class 2 Neurology device (product code GYC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K183437 · Cortec GmbH · Neurology device
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Mar 2019
Decision
90d
Days
Class 2
Risk

K183437 is an FDA 510(k) clearance for the AirRay Subdural Cortical Electrodes. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Cortec GmbH (Freiburg, DE). The FDA issued a Cleared decision on March 12, 2019 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - 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 Cortec GmbH devices

Submission Details

510(k) Number K183437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2018
Decision Date March 12, 2019
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYC Electrode, Cortical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1310
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 - GYC Electrode, Cortical

All 14
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K183437.
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
K191346 · Blackrock Microsystems · Feb 2020
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
K191186 · Ad-Tech Medical Instrument Corporation · Jan 2020
NeuroOne Cortical Electrode
K192764 · Neuroone, Inc. · Nov 2019
SD LTM STIM Cortical Stimulator
K180761 · Micromed S.P.A. · Jun 2018
g.Estim PRO
K173684 · G.Tec Medical Engineering GmbH · May 2018
INTEGRA ELECTRODE TUNNELING NEEDLE
K102802 · Integra LifeSciences Corporation · Nov 2010