Cleared Traditional

K170959 - DIXI Medical Microdeep Depth Electrode
(FDA 510(k) Clearance)

K170959 · Dixi Medical · Neurology
Nov 2017
Decision
238d
Days
Class 2
Risk

K170959 is an FDA 510(k) clearance for the DIXI Medical Microdeep Depth Electrode, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Dixi Medical (Chaudefontaine, FR). The FDA issued a Cleared decision on November 24, 2017, 238 days after receiving the submission on March 31, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K170959 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2017
Decision Date November 24, 2017
Days to Decision 238 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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