Cleared Traditional

K171781 - eVox System

K171781 is an FDA 510(k) clearance for eVox System, manufactured by Evoke Neuroscience, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K171781 · Evoke Neuroscience, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
181d
Days
Class 2
Risk

K171781 is an FDA 510(k) clearance for the eVox System. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Evoke Neuroscience, Inc. (Jacksonville, US). The FDA issued a Cleared decision on December 13, 2017 after a review of 181 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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.

FDA 510(k) Submission Details - K171781

510(k) Number K171781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2017
Decision Date December 13, 2017
Days to Decision 181 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
32d slower than avg
Panel avg: 149d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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

Evoke Neuroscience
Marinela Gombosev

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 - GWQ Full-montage Standard Electroencephalograph

All 182
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K171781.
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K162681 · Neuroelectrics Barcelona S.L.U. · Jun 2017
K171781 · eVox System
Download PDF FDA Summary Evoke Neuroscience, I…