510(k) K261442
- Device
- Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- Applicant
- Cadwell Industries, Inc.
- 510(k) number
- K261442
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-26
- Date received
- 2026-04-30
- Regulation
- 882.1320
- Classification name
- Electrode, Cutaneous
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jason Ford
- Address
- 909 N Kellogg St. Kennewick WA US 99336 99336
FDA Registration Numbers#
- 3003935342
- 9681860
- 3011267903
- 9611558
- 3009171251
- 3017448360
- 2135339
- 3019878714
- 3024892936
- 9610105
- 3003851073
- 1626185
- 1450057
- 3015060202
- 3017970307
- 2031094
- 8010720
- 1055808
- 9617486
- 9710051
- 3006697681
- 1423662
- 9610691
- 3004146401
- 3026753375
- 3010852191
- 3005955744
- 3007748793
- 1921846
- 3003446042
- 3008806011
- 9612389
- 8030229
- 3014647250
- 3022954003
- 3007731000
- 3018070844
- 1423537
- 3012386142
- 3007710601
- 3004920696
- 3012316249
- 1223925
- 2113281
- 3020494684
- 1721293
- 3018094310
- 3003072803
- 8022189
- 3011307234
- 3030978471
- 3005511941
- 3001373226
- 3011506263
- 3011077581
- 3010078417
- 3004839404
- 3004040397
- 3013596024
- 1528161
- 3007502541
- 3016852448
- 3009351773
- 3042268484
- 3014579161
- 8022257
- 3014649088
- 1052723
- 3012176966
- 1043214
- 9616877
- 8030245
- 3009656988
- 3012840029
- 3007028037
- 3023707151
- 3011310592
- 3019822804
- 1317188
Source Documents#
Other 510(k) Records For Product Code GXY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262654 | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | 2026-08-27 |
| 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) | Ambu A/S | 2026-07-14 |
| K261522 | BioWave BioWraps | Biowave Corporation | 2026-06-03 |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 2026-05-08 |
| K254183 | MR Conditional Cup Electrodes | Technomed Europe | 2026-05-07 |
| K252439 | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | 2026-05-01 |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | 2026-04-22 |
| K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | 2026-04-03 |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | 2026-03-12 |
| K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | 2026-02-09 |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | 2025-10-31 |
| K250841 | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. | 2025-08-13 |
| K243788 | IceCap product line | Bioserenity Medical Devices Group | 2025-03-13 |
| K243243 | Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. | 2025-02-06 |
| K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025-01-15 |