Product Code: GXZ FDA class 2 21 CFR 882.1350

Electrode, Needle

Neurology

The Needle Electrode is a fine-gauge electrode inserted through the skin into muscle or nerve tissue to record electrical signals for electromyography (EMG) or nerve conduction diagnostic studies. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GXZ under regulation 21 CFR 882.1350 in the Neurology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GXZ
Device Class: FDA class 2
Regulation Number: 882.1350
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241045	Disposable Subdermal Needle Electrode, Corkscrew	Dec 11, 2024	Substantially Equivalent	Technomed Europe
K232581	Medical Disposable Sterile Needle Electrode	Dec 04, 2023	Substantially Equivalent	Suzhou Haishen Medical Device Associates Co., Ltd.
K231691	Phantom XL Insulated Dilators	Jun 29, 2023	Substantially Equivalent	TeDan Surgical Innovations, Inc.
K200984	Guardian Needle Electrode	May 27, 2020	Substantially Equivalent	Rhythmlink International, LLC
K192603	Spes Medica Subdermal Needle Electrodes	Nov 22, 2019	Substantially Equivalent	Spes Medica Srl
K190801	PressOn Electrode Headset	Jul 10, 2019	Substantially Equivalent	Rhythmlink International, LLC
K161566	DMS Disposable Subdermal Needle Electrodes	Dec 21, 2016	Substantially Equivalent	Daehan Medical Systems Co., Ltd.
K142470	E-Shield Multi-paried Subdermal Needle Electrodes	Nov 05, 2014	Substantially Equivalent	Neuroinvent, Inc.
K140200	E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES	Jul 18, 2014	Substantially Equivalent	Neuroinvent, Inc.
K130220	MR CONDITIONAL PRESSON ELECTRODE	Jul 22, 2013	Substantially Equivalent	Rhythmlink International, LLC
K130136	DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,	Jul 19, 2013	Substantially Equivalent	Technomed Europe
K121347	PRESSON ELECTRODE	Jul 12, 2012	Substantially Equivalent	Rhythmlink International, LLC
K103103	PRESSON ELECTRODE	Dec 08, 2011	Substantially Equivalent	Persyst Development Corp.
K110419	AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS	Jul 28, 2011	Substantially Equivalent	Stryker Spine
K100912	DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE	Aug 19, 2010	Substantially Equivalent	Kirwan Surgical Products, Inc.
K073229	NERVE MONITORING CABLE	Jun 06, 2008	Substantially Equivalent	Pioneer Surgical Technology
K072276	SUBDERMAL NEEDLE ELECTRODES	May 16, 2008	Substantially Equivalent	Xian Friendship Electronics Co., Ltd.
K063729	DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00	Aug 21, 2007	Substantially Equivalent	Technomed Europe
K071185	MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE	May 30, 2007	Substantially Equivalent	Ambu A/S
K062996	DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES	Jan 12, 2007	Substantially Equivalent	Axon Systems, Inc.
K062880	SUBDERMAL WIRE ELECTRODE, MODEL SWE	Dec 22, 2006	Substantially Equivalent	Ives Eeg Solutions, Inc.
K060189	PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)	May 30, 2006	Substantially Equivalent	Ives Eeg Solutions, Inc.
K052111	XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382	Aug 17, 2005	Substantially Equivalent	Excel Tech. , Ltd.
K050325	DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE	May 05, 2005	Substantially Equivalent	Technomed Europe
K050194	AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES	Apr 26, 2005	Substantially Equivalent	Axon Systems, Inc.
K040639	ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE	May 21, 2004	Substantially Equivalent	Isurgical
K023472	LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812	Mar 18, 2003	Substantially Equivalent	Class A Enterprises, Inc.
K022914	RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES	Dec 20, 2002	Substantially Equivalent	Rhythmlink International, LLC
K020910	SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF	Jul 19, 2002	Substantially Equivalent	The Electrode Store, Inc.
K021118	DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570	May 28, 2002	Substantially Equivalent	Class A Ent.
K010019	STERILE SUBDERMAL NEEDLE ELECTRODES	Mar 19, 2001	Substantially Equivalent	Nicolet Biomedical, Inc.
K990100	POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE	Aug 02, 2000	Substantially Equivalent	Te ME NA S.A.R.L.
K990793	ACCUGUIDE MUSCLE INJECTION MONITOR	Oct 22, 1999	Substantially Equivalent	Medtronic Xomed
K983597	NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES	Jan 11, 1999	Substantially Equivalent	Medicotest, Inc.
K974119	DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)	Jan 28, 1998	Substantially Equivalent	Jack'S Electrodes
K950314	DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)	Mar 25, 1996	Substantially Equivalent	Dantec Medical, Inc.
K926094	PROTECTRODE SYSTEM	Dec 06, 1995	Substantially Equivalent	The Electrode Store, Inc.
K934779	AGRAM SPYRAL ELECTRODE	Mar 14, 1995	Substantially Equivalent	Agram Export-Import Co.
K933796	EEG NEEDLE ELECTRODE	Dec 29, 1994	Substantially Equivalent	Cadwell Laboratories, Inc.
K933806	MONOPOLAR EMG NEEDLE ELECTRODE	Apr 22, 1994	Substantially Equivalent	Cadwell Laboratories, Inc.
K933795	CONCENTRIC EMG NEEDLE ELECTRODE	Apr 22, 1994	Substantially Equivalent	Cadwell Laboratories, Inc.
K933793	GROUND/REFERENCE NEEDLE ELECTRODE	Apr 19, 1994	Substantially Equivalent	Cadwell Laboratories, Inc.
K926349	PROBLOC INSULATED NEEDLES	Jul 29, 1993	Substantially Equivalent	Life-Tech Intl., Inc.
K920352	BIO-DETEK EEG ELECTRODE	Aug 14, 1992	Substantially Equivalent	Bio-Detek, Inc.
K912783	DISPOSABLE MONOPOLAR NEEDLE ELECTRODE	Feb 05, 1992	Substantially Equivalent	Class A Ent.
K894911	SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118	May 14, 1990	Substantially Equivalent	Dantec Electronics, Inc.
K901280	DISPOSIBLE EEG NEEDLE ELECTRODES	May 11, 1990	Substantially Equivalent	Medicotest, Inc.
K900740	SPECIMEX DC	May 11, 1990	Substantially Equivalent	Soredex Medical Systems
K896370	DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)	Dec 22, 1989	Substantially Equivalent	Chalgren Enterprises, Inc.
K863136	HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)	Sep 04, 1987	Substantially Equivalent	Neurotechnics, Inc.
K863135	LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)	Sep 04, 1987	Substantially Equivalent	Neurotechnics, Inc.
K850107	CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE	Apr 11, 1985	Substantially Equivalent	Nicolet Biomedical Instruments
K781311	ELECTRODE, NEEDLE, CFM	Aug 21, 1978	Substantially Equivalent	Applied Medical Research