Cleared Traditional

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

K201931 · Dixi Medical · Neurology
Oct 2021
Decision
446d
Days
Class 2
Risk

About This 510(k) Submission

K201931 is an FDA 510(k) clearance for the Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids), a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Dixi Medical (Chaudefontaine, FR). The FDA issued a Cleared decision on October 2, 2021, 446 days after receiving the submission on July 13, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K201931 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2020
Decision Date October 02, 2021
Days to Decision 446 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

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