Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,

Q: What is the product code of K130136?

The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.

FDA 510(k) K130136 · Technomed Europe

Substantially Equivalent

510(k) numberK130136

Submission

Device name: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,
Applicant: Technomed Europe
Maastricht-Airport, NL
Received: January 18, 2013
Decision date: July 19, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GXZ – Electrode, Needle
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1350
Specialty: Neurology

Other 510(k)s with product code GXZ

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K241045	Disposable Subdermal Needle Electrode, CorkscrewGXZ · Traditional	Technomed Europe	12/11/2024SE
K232581	Medical Disposable Sterile Needle ElectrodeGXZ · Traditional	Suzhou Haishen Medical Device Associates Co., Ltd.	12/04/2023SE
K231691	Phantom XL Insulated DilatorsGXZ · Special	TeDan Surgical Innovations, Inc.	06/29/2023SE
K200984	Guardian Needle ElectrodeGXZ · Special	Rhythmlink International, LLC	05/27/2020SE
K192603	Spes Medica Subdermal Needle ElectrodesGXZ · Traditional	Spes Medica Srl	11/22/2019SE
K190801	PressOn Electrode HeadsetGXZ · Traditional	Rhythmlink International, LLC	07/10/2019SE
K161566	DMS Disposable Subdermal Needle ElectrodesGXZ · Traditional	Daehan Medical Systems Co., Ltd.	12/21/2016SE
K142470	E-Shield Multi-paried Subdermal Needle ElectrodesGXZ · Special	Neuroinvent, Inc.	11/05/2014SE
K140200	E-Shield Multi-Paired Subdermal Needle ElectrodesGXZ · Traditional	Neuroinvent, Inc.	07/18/2014SE
K130220	MR Conditional Presson ElectrodeGXZ · Traditional	Rhythmlink International, LLC	07/22/2013SE

More from Rhythmlink International, LLC

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
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
K072016	Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride…GXY · Traditional	10/19/2007SE
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 Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, cleared by the FDA?

Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, (K130136) received a 510(k) decision of Substantially Equivalent on July 19, 2013, 182 days after the submission was received.

What is the product code of K130136?

The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.