Product code GXZ

Device name: Electrode, Needle
Medical specialty: Neurology
Device class: 2
Regulation number: 882.1350
Review panel: NE
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K241045	Disposable Subdermal Needle Electrode, Corkscrew	Technomed Europe	2024-12-11
K232581	Medical Disposable Sterile Needle Electrode	Suzhou Haishen Medical Device Associates Co., Ltd.	2023-12-04
K231691	Phantom XL Insulated Dilators	TeDan Surgical Innovations, Inc.	2023-06-29
K200984	Guardian Needle Electrode	Rhythmlink International, LLC	2020-05-27
K192603	Spes Medica Subdermal Needle Electrodes	Spes Medica Srl	2019-11-22
K190801	PressOn Electrode Headset	Rhythmlink International, LLC	2019-07-10
K161566	DMS Disposable Subdermal Needle Electrodes	Daehan Medical Systems Co., Ltd.	2016-12-21
K142470	E-Shield Multi-paried Subdermal Needle Electrodes	Neuroinvent, Inc.	2014-11-05
K140200	E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES	Neuroinvent, Inc.	2014-07-18
K130220	MR CONDITIONAL PRESSON ELECTRODE	Rhythmlink International, LLC	2013-07-22
K130136	DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,	Technomed Europe	2013-07-19
K121347	PRESSON ELECTRODE	Rhythmlink International, LLC	2012-07-12
K103103	PRESSON ELECTRODE	Persyst Development Corp.	2011-12-08
K110419	AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS	Stryker Spine	2011-07-28
K100912	DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE	Kirwan Surgical Products, Inc.	2010-08-19
K073229	NERVE MONITORING CABLE	Pioneer Surgical Technology	2008-06-06
K072276	SUBDERMAL NEEDLE ELECTRODES	Xian Friendship Electronics Co., Ltd.	2008-05-16
K063729	DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00	Technomed Europe	2007-08-21
K071185	MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE	Ambu A/S	2007-05-30
K062996	DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES	Axon Systems, Inc.	2007-01-12
K062880	SUBDERMAL WIRE ELECTRODE, MODEL SWE	Ives Eeg Solutions, Inc.	2006-12-22
K060189	PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)	Ives Eeg Solutions, Inc.	2006-05-30
K052111	XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382	Excel Tech. , Ltd.	2005-08-17
K050325	DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE	Technomed Europe	2005-05-05
K050194	AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES	Axon Systems, Inc.	2005-04-26
K040639	ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE	Isurgical	2004-05-21
K023472	LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812	Class A Enterprises, Inc.	2003-03-18
K022914	RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES	Rhythmlink International, LLC	2002-12-20
K020910	SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF	The Electrode Store, Inc.	2002-07-19
K021118	DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570	Class A Ent.	2002-05-28

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08718375861707	Technomed Europe	Technomed Engineering B.V.	2019-11-21
08718375862346	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861660	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862339	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862322	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862315	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862124	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862117	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862100	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862094	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862087	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862070	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862063	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862056	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862049	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862032	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862025	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862018	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375862001	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861998	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861981	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861974	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861967	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861950	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861943	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861936	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861929	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861912	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861905	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861899	Technomed Europe	Technomed Engineering B.V.	2016-09-22

Product code GXZ

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