Cleared Traditional

K162460 - WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts

K162460 is an FDA 510(k) clearance for WAVi Headset and WAVi eSoc Single Use E..., manufactured by Wavi Co.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K162460 · Wavi Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
238d
Days
Class 2
Risk

K162460 is an FDA 510(k) clearance for the WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Wavi Co. (Englewood, US). The FDA issued a Cleared decision on April 28, 2017 after a review of 238 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Wavi Co. devices

FDA 510(k) Submission Details - K162460

510(k) Number K162460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2016
Decision Date April 28, 2017
Days to Decision 238 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 149d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 Peers - GXY Electrode, Cutaneous

All 344
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K162460.
Disposable Snap Electrode
K172703 · Embla Systems · Nov 2017
Ceribell Instant EEG Headband
K171459 · Ceribell, Inc. · Aug 2017
Adhesive Electrodes
K170744 · Reno Medical , Ltd. · May 2017
Complete Control System
K162891 · Coapt, LLC · Apr 2017
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
K163547 · Neurovirtual USA, Inc. · Apr 2017
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
K161282 · Medico Electrodes International , Ltd. · Oct 2016