Product code GXY— Neurology
Adhesive Electrodes
- Classification name
- Electrode, Cutaneous
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Total cleared
- 440
- First cleared
- Most recent
Market context for product code GXY
FDA has cleared devices under product code GXY between 1976 and 2026, filed by 255 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code GXY
Recent clearances under product code GXY
1–100 of 440- K262654 — Dexus Prosthetic System (MSL2, MSR2)
- K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- K261522 — BioWave BioWraps
- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
- K254183 — MR Conditional Cup Electrodes
- K252439 — Tutamen Self Adhesive Electrodes
- K253256 — myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
- K260363 — Ceribell Brain Monitor Headband
- K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
- K254033 — Ceribell Instant EEG Headset
- K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
- K250841 — Electrotherapy Electrodes
- K243788 — IceCap product line
- K243243 — Delphi MCS Electrode Cap
- K241512 — Electrode Pad
- K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50)
- K241160 — CAIs Sensor (CAIs-001)
- K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
- K242346 — Grass® MR Conditional/CT Cup Electrodes
- K240108 — Wrap Accessory Electrodes (GMX-ABSBELT01 +8 more
- K240884 — Glide (91000-GL-X)
- K240668 — Amydi-med Disposable Non-invasive EEG electrodes
- K232995 — Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005 +4 more
- K221199 — Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)
- K231164 — Conductive carbon film electrode
- K231167 — Conductive Silicone Rubber Electrode
- K232052 — Ceribell Instant EEG Headband
- K221589 — Starly pad
- K223086 — Ceribell Instant EEG Headcap
- K230533 — Motive Electrode
- K222671 — DeltaScan Patch
- K222863 — Garment Electrodes
- K220448 — Disposable Non-invasive EEG Sensor
- K222252 — Self-adhesive Electrode
- K223738 — Alpha Control Liner System (ACLS)
- K223775 — EZ-STIK Electrodes
- K223605 — ControlSeal Electrode (ELSB)
- K222453 — Self-adhesive Electrode
- K220002 — Dexus Prosthetics System (Model: MSL1, MSR1)
- K213884 — Disposable EEG cable
- K213879 — Self-adhesive Electrode
- K210383 — Wrap Accessory Electrodes
- K211315 — Comby EEG Caps
- K212191 — Adhesive Electrodes
- K210448 — Adhesive Electrode
- K210805 — Ceribell Instant EEG Headband
- K202636 — Metallic Fabric Electrodes
- K211839 — Electrode Market Disposable Surface Electrodes
- K203158 — BioWave BioWraps
- K200942 — Well-Life Garment Electrodes (GM Series)
- K202913 — NeuroCap (Model DEC22)
- K203079 — MR Conditional Sticky Pad Electrode
- K192568 — Jiajian Self-Adhesive Electrode
- K200540 — BRAINSTREAM Disposable Deep Cup EEG Electrodes
- K190118 — Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
- K200162 — Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
- K192564 — Disposable Gold Cup EEG Electrodes
- K191179 — Myo Plus
- K191225 — EEG Electrode Template
- K190617 — Wrap accessory electrodes
- K190700 — ELECTRODES PAD
- K191083 — COMPLETE CONTROL System Gen2
- K190416 — Dome Electrode
- K180232 — DAEHAN Disposable CUP Electrodes
- K183154 — SM Electrodes
- K182111 — DL Self-adhesive Electrode
- K182757 — Espire Elbow Pro, Espire Elbow Hybrid
- K180247 — DAEHAN Adhesive Surface Electrodes
- K182112 — Sense System with IBT Electrodes
- K181234 — Self-adhesive Electrode
- K180865 — ZMI Self-Adhesive Electrodes
- K171798 — Silverwear Silver Pro Garment Device
- K180773 — Reusable and Self-Adhesive Electrodes
- K180524 — EEG-Now
- K172866 — NeuroCap
- K172887 — XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)
- K173571 — Element System with IBT Electrodes
- K173186 — S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
- K171722 — Electrodes with snap / Electrodes with pigtail
- K171721 — Electrodes with silver conductive
- K171102 — Ives MR Conditional Cup Electrode
- K171381 — Adhesive Electrodes
- K172503 — MR Conditional Cup Electrode, MR Conditional Webb Electrode
- K172703 — Disposable Snap Electrode
- K171459 — Ceribell Instant EEG Headband
- K170744 — Adhesive Electrodes
- K162460 — WAVi Headset and WAVi eSoc Single Use Electrode Contacts
- K162891 — Complete Control System
- K163547 — MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
- K161282 — FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
- K160081 — TENS Electrodes
- K160138 — Adhesive Electrodes
- K153019 — Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
- K152815 — Mailuokang Self-adhesive Electrode
- K152648 — Ennova Self-adhesive Electrode
- K151693 — Dr-Ho's Foot Pad Electrode
- K151576 — Neon EEG
- K150971 — Zekang Self-adhesive Electrode
- K151033 — Philips Self-Adhesive Electrodes
Data sourced from openFDA. This site is unofficial and independent of the FDA.