GXY — Electrode, Cutaneous Class II
FDA product code GXY covers "Electrode, Cutaneous", a Class II medical device regulated under 21 CFR 882.1320. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260578 | ambu | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/ | July 14, 2026 |
| K261442 | cadwell industries | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electr | June 26, 2026 |
| K261522 | biowave corporation | BioWave BioWraps | June 3, 2026 |
| K253237 | elde medikal sanayi ve ticaret anonim sirketi | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | May 8, 2026 |
| K254183 | technomed europe | MR Conditional Cup Electrodes | May 7, 2026 |
| K252439 | dongguan tutamen metalwork co | Tutamen Self Adhesive Electrodes | May 1, 2026 |
| K253256 | otto bock healthcare products | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart | April 22, 2026 |
| K260363 | ceribell | Ceribell Brain Monitor Headband | April 3, 2026 |
| K260453 | bionit labs | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | March 12, 2026 |
| K254033 | ceribell | Ceribell Instant EEG Headset | February 9, 2026 |
| K251381 | ceribell | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | October 31, 2025 |
| K250841 | baisheng medical co | Electrotherapy Electrodes | August 13, 2025 |
| K243788 | bioserenity medical devices group | IceCap product line | March 13, 2025 |
| K243243 | quantalx neuroscience | Delphi MCS Electrode Cap | February 6, 2025 |
| K241512 | shenzhen deliduo medical technology co | Electrode Pad | January 15, 2025 |
| K242326 | bionit labs | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | January 2, 2025 |
| K241160 | brainu co | CAIs Sensor (CAIs-001) | December 13, 2024 |
| K240575 | eemagine medical imaging solutions | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | November 25, 2024 |
| K242346 | natus manufacturing limited | Grass® MR Conditional/CT Cup Electrodes | August 29, 2024 |
| K240108 | gymmax technology shenzhen co | Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW0 | June 10, 2024 |