GXY — Electrode, Cutaneous Class II

FDA Device Classification

Classification Details

Product Code
GXY
Device Class
Class II
Regulation Number
882.1320
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K260453bionit labsRemote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)March 12, 2026
K254033ceribellCeribell Instant EEG HeadsetFebruary 9, 2026
K251381ceribellCeribell Instant EEG Headcap (Small: C251, Medium: C252)October 31, 2025
K250841baisheng medical coElectrotherapy ElectrodesAugust 13, 2025
K243788bioserenity medical devices groupIceCap product lineMarch 13, 2025
K243243quantalx neuroscienceDelphi MCS Electrode CapFebruary 6, 2025
K241512shenzhen deliduo medical technology coElectrode PadJanuary 15, 2025
K242326bionit labsWave Electrode (AE02-60); Wave Electrode (AE02-50)January 2, 2025
K241160brainu coCAIs Sensor (CAIs-001)December 13, 2024
K240575eemagine medical imaging solutionsWaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)November 25, 2024
K242346natus manufacturing limitedGrass® MR Conditional/CT Cup ElectrodesAugust 29, 2024
K240108gymmax technology shenzhen coWrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW0June 10, 2024
K240884infinite biomedical technologiesGlide (91000-GL-X)April 15, 2024
K240668shenzhen amydi-med electrics tech coAmydi-med Disposable Non-invasive EEG electrodesMarch 19, 2024
K232995shenzhen roundwhale technology co.Neurological Therapy Devices - Accessories: Electrotherapy device Electrode beltJanuary 11, 2024
K221199green island international tcm group limitedConductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, PoiDecember 19, 2023
K231164guangzhou xinbo electronic coConductive carbon film electrodeAugust 9, 2023
K231167guangzhou xinbo electronic coConductive Silicone Rubber ElectrodeAugust 9, 2023
K232052ceribellCeribell Instant EEG HeadbandAugust 8, 2023
K221589shenzhen xingyuanli technology coStarly padMarch 24, 2023