Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable

Q: What is the product code of K072016?

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

FDA 510(k) K072016 · Technomed Europe

Substantially Equivalent

510(k) numberK072016

Submission

Device name: Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable
Applicant: Technomed Europe
Maastricht-Airport, NL
Received: July 23, 2007
Decision date: October 19, 2007
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
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
K254183	MR Conditional Cup ElectrodesGXY · Traditional	05/07/2026SE
K253581	Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional	03/15/2026SE
K241045	Disposable Subdermal Needle Electrode, CorkscrewGXZ · Traditional	12/11/2024SE
K130136	Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…GXZ · Traditional	07/19/2013SE
K121257	Laryngeal ElectrodeETN · Traditional	08/28/2012SE
K110422	Surgical StimulatorsETN · Traditional	05/26/2011SE
K073532	Disposable Adhesive Surface Electrodes, Disc ElectrodesGXY · Traditional	05/01/2008SE
K063729	Disposable Pedicle Screw Probe, Model 3603-00GXZ · Traditional	08/21/2007SE
K062437	Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledIKT · Traditional	02/16/2007SE
K050325	Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar ProbeGXZ · Traditional	05/05/2005SE

Questions and answers

When was Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable cleared by the FDA?

Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable (K072016) received a 510(k) decision of Substantially Equivalent on October 19, 2007, 88 days after the submission was received.

What is the product code of K072016?

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