Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

Q: What is the product code of K201931?

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

FDA 510(k) K201931 · Dixi Medical

Substantially Equivalent

510(k) numberK201931

Submission

Device name: Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
Applicant: Dixi Medical
Chaudefontaine, FR
Received: July 13, 2020
Decision date: October 2, 2021
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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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
K191346	Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)GYC · Traditional	Blackrock Microsystems	02/14/2020SE
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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

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Questions and answers

When was Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) cleared by the FDA?

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) (K201931) received a 510(k) decision of Substantially Equivalent on October 2, 2021, 446 days after the submission was received.

What is the product code of K201931?

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