Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1320](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1320) → GXY — Electrode, Cutaneous

# GXY · Electrode, Cutaneous

_Neurology · 21 CFR 882.1320 · Class 2_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/GXY

## Overview

- **Product Code:** GXY
- **Device Name:** Electrode, Cutaneous
- **Regulation:** [21 CFR 882.1320](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1320)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 440)

Showing 20 most recent of 440 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K262654](/device/K262654.md) | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | Aug 27, 2026 | SESE |
| [K260578](/device/K260578.md) | 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) | Ambu A/S | Jul 14, 2026 | SESE |
| [K261442](/device/K261442.md) | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | Jun 26, 2026 | SESE |
| [K261522](/device/K261522.md) | BioWave BioWraps | Biowave Corporation | Jun 3, 2026 | SESE |
| [K253237](/device/K253237.md) | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | May 8, 2026 | SESE |
| [K254183](/device/K254183.md) | MR Conditional Cup Electrodes | Technomed Europe | May 7, 2026 | SESE |
| [K252439](/device/K252439.md) | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | May 1, 2026 | SESE |
| [K253256](/device/K253256.md) | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | Apr 22, 2026 | SESE |
| [K260363](/device/K260363.md) | Ceribell Brain Monitor Headband | Ceribell, Inc. | Apr 3, 2026 | SESE |
| [K260453](/device/K260453.md) | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | Mar 12, 2026 | SESE |
| [K254033](/device/K254033.md) | Ceribell Instant EEG Headset | Ceribell, Inc. | Feb 9, 2026 | SESE |
| [K251381](/device/K251381.md) | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | Oct 31, 2025 | SESE |
| [K250841](/device/K250841.md) | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. | Aug 13, 2025 | SESE |
| [K243788](/device/K243788.md) | IceCap product line | Bioserenity Medical Devices Group | Mar 13, 2025 | SESE |
| [K243243](/device/K243243.md) | Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. | Feb 6, 2025 | SESE |
| [K241512](/device/K241512.md) | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | Jan 15, 2025 | SESE |
| [K242326](/device/K242326.md) | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | Jan 2, 2025 | SESE |
| [K241160](/device/K241160.md) | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | Dec 13, 2024 | SESE |
| [K240575](/device/K240575.md) | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | Eemagine Medical Imaging Solutions GmbH | Nov 25, 2024 | SESE |
| [K242346](/device/K242346.md) | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | Aug 29, 2024 | SESE |

## Top Applicants

- Empi — 10 clearances
- Medtronic Vascular — 10 clearances
- Aspect Medical Systems, Inc. — 9 clearances
- Labeltape Meditect, Inc. — 9 clearances
- Axelgaard Mfg. Co., Ltd. — 8 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/GXY](https://fda-staging.innolitics.com/productcode/GXY)

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