Cleared Traditional

Evo sEEG System (K211367) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211367 · Neuroone Medical Technologies Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
120d
Days
Class 2
Risk

K211367 is an FDA 510(k) clearance for the Evo sEEG System. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Neuroone Medical Technologies Corp. (Eden Prairie, US). The FDA issued a Cleared decision on September 1, 2021 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neuroone Medical Technologies Corp. devices

Submission Details

510(k) Number K211367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2021
Decision Date September 01, 2021
Days to Decision 120 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 148d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Ostendorf Consulting, LLC
Joseph Ostendorf

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZL Electrode, Depth

All 15
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K211367.
Evo® sEEG System
K222404 · Neuroone Medical Technologies Corp. · Oct 2022
Neuro Omega System, NeuroSmart System
K220553 · Alpha Omega Engineering , Ltd. · Sep 2022
DIXI Medical Microdeep Micro-Macro Depth Electrodes
K202087 · Dixi Medical · Nov 2021
iCE-SG Subcutaneous Electrode Arrays
K201678 · Ice Neurosystems, Inc. · Mar 2021
Sterile LeadConfirm
K191739 · Alpha Omega Engineering , Ltd. · Jan 2020
microTargeting Guideline 4000 5.0 System
K183123 · FHC, Inc. · Dec 2018