Cleared Special

K173186 - S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D

K173186 is an FDA 510(k) clearance for S Series Electrodes / Models S55105, manufactured by Everyway Medical Instruments Co.,Ltd. The device is a Class 2 Neurology device with product code GXY cleared through the Special 510(k) pathway after a 149-day FDA review.

K173186 · Everyway Medical Instruments Co.,Ltd · Neurology device
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Feb 2018
Decision
149d
Days
Class 2
Risk

K173186 is an FDA 510(k) clearance for the S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, S.... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (New Taipei City, TW). The FDA issued a Cleared decision on February 28, 2018 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K173186

510(k) Number K173186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date February 28, 2018
Days to Decision 149 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 149d · This submission: 149d
Pathway characteristics
Modification to existing cleared device.

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 440
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K173186.
NeuroCap
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K171722 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018
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K171721 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018
Ives MR Conditional Cup Electrode
K171102 · Ives Egg Solutions · Dec 2017
K173186 · S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
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