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-Number | Applicant | Device Name | Date |
|---|
| 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 |
| K240884 | infinite biomedical technologies | Glide (91000-GL-X) | April 15, 2024 |
| K240668 | shenzhen amydi-med electrics tech co | Amydi-med Disposable Non-invasive EEG electrodes | March 19, 2024 |