Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

Q: What is the product code of K191346?

The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.

FDA 510(k) K191346 · Blackrock Microsystems

Substantially Equivalent

510(k) numberK191346

Submission

Device name: Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
Applicant: Blackrock Microsystems
Salt Lake City, UT, US
Received: May 20, 2019
Decision date: February 14, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GYC – Electrode, Cortical
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1310
Specialty: Neurology

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K250094	Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…GYC · Traditional	Neuralynx, Inc.	04/14/2025SE
K242618	Layer 7-TGYC · Traditional	Precision Neuroscience, Corp.	03/30/2025SE
K221123	WISE Cortical Strip (WCS)GYC · Traditional	Wise S.R.L.	11/22/2022SE
K211954	Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip…GYC · Traditional	Spes Medica Srl	11/10/2022SE
K201931	Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)GYC · Traditional	Dixi Medical	10/02/2021SE
K191186	Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…GYC · Traditional	Ad-Tech Medical Instrument Corporation	01/25/2020SE
K192764	NeuroOne Cortical ElectrodeGYC · Traditional	Neuroone, Inc.	11/26/2019SE
K183437	AirRay Subdural Cortical ElectrodesGYC · Traditional	Cortec GmbH	03/12/2019SE
K180761	SD LTM STIM Cortical StimulatorGYC · Traditional	Micromed S.P.A.	06/18/2018SE
K173684	g.Estim PROGYC · Traditional	G.Tec Medical Engineering GmbH	05/04/2018SE

More from G.Tec Medical Engineering GmbH

510(k)	Device	Decision
K202174	Digital NeuroPort Biopotential Signal Processing SystemGWL · Special	02/10/2021SE
K110010	Neuroport Cortical Microelectrode Array SystemGZL · Special	02/09/2011SE

Questions and answers

When was Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) cleared by the FDA?

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) (K191346) received a 510(k) decision of Substantially Equivalent on February 14, 2020, 270 days after the submission was received.

What is the product code of K191346?

The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.