Cleared Traditional

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

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

About This 510(k) Submission

K191346 is an FDA 510(k) clearance for the Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids), a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Blackrock Microsystems (Salt Lake City, US). The FDA issued a Cleared decision on February 14, 2020, 270 days after receiving the submission on May 20, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K191346 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GYC — Electrode, Cortical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1310

Similar Devices — GYC Electrode, Cortical

All 31
Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
K250094 · Neuralynx, Inc. · Apr 2025
Layer 7-T
K242618 · Precision Neuroscience, Corp. · Mar 2025
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