Cleared Traditional

Evo? sEEG System

K222404 · Neuroone Medical Technologies Corp. · Neurology
Oct 2022
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K222404 is an FDA 510(k) clearance for the Evo? sEEG System, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Neuroone Medical Technologies Corp. (Eden Prairie, US). The FDA issued a Cleared decision on October 20, 2022, 72 days after receiving the submission on August 9, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K222404 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2022
Decision Date October 20, 2022
Days to Decision 72 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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