Monotrode Cutaneous Electrode

Q: What is the product code of K915864?

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

FDA 510(k) K915864 · Henley Intl.

Substantially Equivalent

510(k) numberK915864

Submission

Device name: Monotrode Cutaneous Electrode
Applicant: Henley Intl.
Sugar Land, TX, US
Received: December 31, 1991
Decision date: July 21, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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

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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
K253237	Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)GXY · Traditional	Elde Medikal Sanayi ve Ticaret Anonim Sirketi	05/08/2026SE
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

More from Bionit Labs Srl

510(k)	Device	Decision
K943449	Neurological Diagnostic DevicesGXY · Traditional	11/15/1995SE
K926279	Upper Body ExerciserISD · Traditional	05/05/1994SE
K926278	Stair ClimberISD · Traditional	05/05/1994SE
K926287	Exercise BicycleISD · Traditional	03/22/1994SE
K926314	Hydra Fitness Model 311 Total PowerISD · Traditional	03/18/1994SE
K926313	Computerized Testing and Exercise SystemsBXB · Traditional	02/04/1994SE
K922036	Sonopuls 591IMG · Traditional	06/29/1993SE
K926316	True-Trac, StratusJFB · Traditional	03/24/1993SE
K920983	Sonopuls 590IMI · Traditional	03/09/1993SE
K922020	Endomed 582LIH · Traditional	09/22/1992SE

Questions and answers

When was Monotrode Cutaneous Electrode cleared by the FDA?

Monotrode Cutaneous Electrode (K915864) received a 510(k) decision of Substantially Equivalent on July 21, 1993, 568 days after the submission was received.

What is the product code of K915864?

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