510(k) K253237
- Device
- Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
- Applicant
- Elde Medikal Sanayi ve Ticaret Anonim Sirketi
- 510(k) number
- K253237
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-08
- Date received
- 2025-09-29
- Regulation
- 882.1320
- Classification name
- Electrode, Cutaneous
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Nurettin Eren
- Address
- Necip Fazil Bulvari Keyap Carsi Sitesi No: 44 D-1 Blok Dukkan No: 53/2 Umraniye/Istanbul TR 34775 34775
FDA Registration Numbers#
- 2936999
- 3011267903
- 3013557562
- 3014647250
- 3022631685
- 3024892936
- 8022257
- 9612243
- 3023164
- 3027718340
- 3031464228
- 3045752480
- 3011412151
- 3009351773
- 3030978471
- 3010078417
- 3010097863
- 3045321552
- 3013426279
- 3003935342
- 3004558433
- 9681377
- 3009555600
- 9612330
- 3012321270
- 1650946
- 3006551156
- 3004753827
- 1045254
- 9710602
- 3020018
- 3002923871
- 1420295
- 3013298431
- 3046649655
- 2221819
- 1056553
- 3017450375
- 3006850006
- 3000947648
- 1644243
- 3005581270
- 3014027738
- 3043013796
- 3011534533
- 1930027
- 3015614098
- 3044563261
- 3013671142
- 3008197884
- 3008806011
- 2183164
- 3027329006
- 2135339
- 3003851073
- 9616086
- 2132556
- 3012316249
- 1417592
- 3009831876
- 2025066
- 3033509895
- 3004040397
- 3011766844
- 3007028037
- 9710051
- 8020045
- 3003573572
- 3015429360
- 3007048259
- 3010611950
- 3007502541
- 9681860
- 3015531976
- 3005170249
- 3030151584
- 3019822804
- 3005463575
- 3004839404
- 3013378804
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 |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | 2026-06-26 |
| K261522 | BioWave BioWraps | Biowave Corporation | 2026-06-03 |
| 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 |