Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)— 510(k) K201931

Name: FDA 510(k) clearance K201931
Creator: U.S. Food and Drug Administration
Published: 2021-10-02

Substantially Equivalent

Dixi Medical

FDA 510(k) clearance K201931 for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids), Substantially Equivalent on 2021-10-02. Applicant: Dixi Medical. Device class: 2.

Clearance details

Applicant: Dixi Medical
Product code: Code GYC
Device class: Class 2
Regulation: 21 CFR 882.1310
Advisory panel: Neurology
Date received: 2020-07-13
Decision date: 2021-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaudefontaine, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code GYC

view all

K250094 — Atlas Stim Headbox (NK) (31-0601-0077) +9 more2025-04-14
K242618 — Layer 7-T2025-03-30
K221123 — WISE Cortical Strip (WCS)2022-11-22
K211954 — Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid2022-11-10
K191346 — Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)2020-02-14

More clearances from Dixi Medical

view all

K202087 — DIXI Medical Microdeep Micro-Macro Depth Electrodes2021-11-18
K170959 — DIXI Medical Microdeep Depth Electrode2017-11-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.