Cleared Traditional

K191346 - Blackrock NeuroCoG Subdural Cortical El...

K191346 is an FDA 510(k) clearance for Blackrock NeuroCoG Subdural Cortical El..., manufactured by Blackrock Microsystems. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K191346 · Blackrock Microsystems · Neurology device
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Feb 2020
Decision
270d
Days
Class 2
Risk

K191346 is an FDA 510(k) clearance for the Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids). Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Blackrock Microsystems (Salt Lake City, US). The FDA issued a Cleared decision on February 14, 2020 after a review of 270 days - an extended review cycle.

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 Blackrock Microsystems devices

FDA 510(k) Submission Details - K191346

510(k) Number K191346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2019
Decision Date February 14, 2020
Days to Decision 270 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
122d slower than avg
Panel avg: 148d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYC Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K191346.
WISE Cortical Strip (WCS)
K221123 · Wise S.R.L. · Nov 2022
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
K211954 · Spes Medica Srl · Nov 2022
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
K201931 · Dixi Medical · Oct 2021
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
AirRay Subdural Cortical Electrodes
K183437 · Cortec GmbH · Mar 2019