DMS Disposable Subdermal Needle Electrodes

Q: What is the product code of K161566?

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

FDA 510(k) K161566 · Daehan Medical Systems Co., Ltd.

Substantially Equivalent

510(k) numberK161566

Submission

Device name: DMS Disposable Subdermal Needle Electrodes
Applicant: Daehan Medical Systems Co., Ltd.
Siheung-City, KR
Received: June 6, 2016
Decision date: December 21, 2016
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

510(k)	Device	Applicant	Decision
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
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
K130136	Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…GXZ · Traditional	Technomed Europe	07/19/2013SE

More from Technomed Europe

510(k)	Device	Decision
K180232	DAEHAN Disposable CUP ElectrodesGXY · Traditional	04/03/2019SE
K180247	DAEHAN Adhesive Surface ElectrodesGXY · Traditional	11/01/2018SE

Questions and answers

When was DMS Disposable Subdermal Needle Electrodes cleared by the FDA?

DMS Disposable Subdermal Needle Electrodes (K161566) received a 510(k) decision of Substantially Equivalent on December 21, 2016, 198 days after the submission was received.

What is the product code of K161566?

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