Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

Q: What is the product code of K253237?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.

FDA 510(k) K253237 · Elde Medikal Sanayi ve Ticaret Anonim Sirketi

Substantially Equivalent

510(k) numberK253237

Submission

Device name: Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
Applicant: Elde Medikal Sanayi ve Ticaret Anonim Sirketi
Umraniye/Istanbul, TR
Received: September 29, 2025
Decision date: May 8, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GXY – Electrode, Cutaneous
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1320
Specialty: Neurology

Other 510(k)s with product code GXY

510(k)	Device	Applicant	Decision
K262654	Dexus Prosthetic System (MSL2, MSR2)GXY · Special	Zhejiang Qiangnao Technology Co.,Ltd	08/27/2026SE
K260578	Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…GXY · Traditional	Ambu A/S	07/14/2026SE
K261442	Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayGXY · Abbreviated	Cadwell Industries, Inc.	06/26/2026SE
K261522	BioWave BioWrapsGXY · Special	Biowave Corporation	06/03/2026SE
K254183	MR Conditional Cup ElectrodesGXY · Traditional	Technomed Europe	05/07/2026SE
K252439	Tutamen Self Adhesive ElectrodesGXY · Traditional	Dongguan Tutamen Metalwork Co., Ltd.	05/01/2026SE
K253256	myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…GXY · Traditional	Otto Bock Healthcare Products GmbH	04/22/2026SE
K260363	Ceribell Brain Monitor HeadbandGXY · Abbreviated	Ceribell, Inc.	04/03/2026SE
K260453	Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)GXY · Special	Bionit Labs Srl	03/12/2026SE
K254033	Ceribell Instant EEG HeadsetGXY · Abbreviated	Ceribell, Inc.	02/09/2026SE

Questions and answers

When was Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) cleared by the FDA?

Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) (K253237) received a 510(k) decision of Substantially Equivalent on May 8, 2026, 221 days after the submission was received.

What is the product code of K253237?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.