GXY
- 产品代码
- GXY
- 器械名称
- Electrode, Cutaneous
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 882.1320
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 440 件
该代码近三年的 510(k)（25 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K262654 | 2026-08-27 | Zhejiang Qiangnao Technology Co.,Ltd | Dexus Prosthetic System (MSL2, MSR2) | |
| K260578 | 2026-07-14 | Ambu A/S | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72 | |
| K261442 | 2026-06-26 | Cadwell Industries, Inc. | Charlotte ACC25 Surface Electrode Array; Charlotte A | |
| K261522 | 2026-06-03 | Biowave Corporation | BioWave BioWraps | |
| K253237 | 2026-05-08 | Elde Medikal Sanayi ve Ticaret Anonim | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T1 | |
| K254183 | 2026-05-07 | Technomed Europe | MR Conditional Cup Electrodes | |
| K252439 | 2026-05-01 | Dongguan Tutamen Metalwork Co., Ltd. | Tutamen Self Adhesive Electrodes | |
| K253256 | 2026-04-22 | Otto Bock Healthcare Products GmbH | myosmart. (13E522); myosmart.cuff (757M20-2); connec | |
| K260363 | 2026-04-03 | Ceribell, Inc. | Ceribell Brain Monitor Headband | |
| K260453 | 2026-03-12 | Bionit Labs Srl | Remote Wave Electrode (AE03-50); Remote Wave Electro | |
| K254033 | 2026-02-09 | Ceribell, Inc. | Ceribell Instant EEG Headset | |
| K251381 | 2025-10-31 | Ceribell, Inc. | Ceribell Instant EEG Headcap (Small: C251, Medium: C | |
| K250841 | 2025-08-13 | Baisheng Medical Co., Ltd. | Electrotherapy Electrodes | |
| K243788 | 2025-03-13 | Bioserenity Medical Devices Group | IceCap product line | |
| K243243 | 2025-02-06 | Quantalx Neuroscience, Ltd. | Delphi MCS Electrode Cap | |
| K241512 | 2025-01-15 | Shenzhen Deliduo Medical Technology Co | Electrode Pad | |
| K242326 | 2025-01-02 | Bionit Labs Srl | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | |
| K241160 | 2024-12-13 | Brainu Co., Ltd. | CAIs Sensor (CAIs-001) | |
| K240575 | 2024-11-25 | Eemagine Medical Imaging Solutions Gmb | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-26 | |
| K242346 | 2024-08-29 | Natus Manufacturing Limited | Grass® MR Conditional/CT Cup Electrodes | |
| K240108 | 2024-06-10 | Gymmax Technology Shenzhen Co., Ltd. | Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBEL | |
| K240884 | 2024-04-15 | Infinite Biomedical Technologies, LLC | Glide (91000-GL-X) | |
| K240668 | 2024-03-19 | Shenzhen Amydi-Med Electrics Tech Co., | Amydi-med Disposable Non-invasive EEG electrodes | |
| K232995 | 2024-01-11 | Shenzhen Roundwhale Technology Co. , L | Neurological Therapy Devices - Accessories: Electrot | |
| K221199 | 2023-12-19 | Green Island International Tcm Group L | Conductive Silicone Electrode (model: Foot Pad Elect | — |
FDA 官方分类页： GXY
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。