Evo® sEEG System

FDA 510(k) K222404 · Neuroone Medical Technologies Corp.

Substantially Equivalent

510(k) numberK222404

Submission

Device name
Evo® sEEG System
Applicant
Neuroone Medical Technologies Corp.
Eden Prairie, MN, US
Received
August 9, 2022
Decision date
October 20, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZL – Electrode, Depth
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1330
Specialty
Neurology

Other 510(k)s with product code GZL

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K253970Wovyn Depth ElectrodeGZL · Traditional Sensomedical Labs, Ltd.04/17/2026SE
K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…GZL · Traditional Beijing Sinovation Medical Technology Co., Ltd.11/05/2025SE
K250601Neuro Omega System; NeuroSmart SystemGZL · Special Alpha Omega Engineering , Ltd.03/30/2025SE
K223276Anchor Bolts as Accessories to Depth ElectrodesGZL · Traditional Ad-Tech Medical Instrument Corporation05/18/2023SE
K223269Spencer Probe Depth ElectrodesGZL · Traditional Ad-Tech Medical Instrument Corporation05/18/2023SE
K213170SENSOSEEG Depth ElectrodesGZL · Traditional Sensomedical Labs, Ltd.04/18/2023SE
K222706iCE-SG2 Subcutaneous Electrode KitGZL · Traditional Ice Neurosystems, Inc.12/06/2022SE
K220553Neuro Omega System, NeuroSmart SystemGZL · Special Alpha Omega Engineering , Ltd.09/16/2022SE
K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesGZL · Traditional Dixi Medical11/18/2021SE
K211367Evo sEEG SystemGZL · Traditional Neuroone Medical Technologies Corp.09/01/2021SE

More from Neuroone Medical Technologies Corp.

510(k)DeviceDecision
K251243OneRF Trigeminal Nerve Radiofrequency ProbesGXI · Traditional 08/15/2025SE
K231675OneRF Ablation SystemGXD · Traditional 12/06/2023SE
K211367Evo sEEG SystemGZL · Traditional 09/01/2021SE

Questions and answers

When was Evo® sEEG System cleared by the FDA?

Evo® sEEG System (K222404) received a 510(k) decision of Substantially Equivalent on October 20, 2022, 72 days after the submission was received.

What is the product code of K222404?

The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.