Cleared Traditional

K202087 - DIXI Medical Microdeep Micro-Macro Depth Electrodes
(FDA 510(k) Clearance)

K202087 · Dixi Medical · Neurology
Nov 2021
Decision
478d
Days
Class 2
Risk

K202087 is an FDA 510(k) clearance for the DIXI Medical Microdeep Micro-Macro Depth Electrodes, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Dixi Medical (Chaudefontaine, FR). The FDA issued a Cleared decision on November 18, 2021, 478 days after receiving the submission on July 28, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K202087 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2020
Decision Date November 18, 2021
Days to Decision 478 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZL — Electrode, Depth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1330

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