Product code IKT

Device name: Electrode, Needle, Diagnostic Electromyograph
Medical specialty: Physical Medicine
Device class: 2
Regulation number: 890.1385
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
K253581	Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric N...	Technomed Europe	2026-03-15
K173815	Allergan Botox Needle Electrode	Natus Manufacturing Limited	2018-06-29
K161430	Myoject Luer Lock Needle Electrode	Natus Manufacturing Limited	2017-03-02
K152984	Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes	Bio Protech, Inc.	2016-06-03
K143433	Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm	Natus Manufacturing Limited	2015-08-28
K120342	EMG RECORDING ELECTRODE ASSEMBLY	Rhythmlink International, LLC	2012-06-22
K112034	TECA ELITE DISPOSABLE CONCENTRIC NEEDLES	Carefusion 209, Inc.	2011-08-12
K111131	TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES	Carefusion 209, Inc.	2011-06-17
K092973	DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE	Bionen S.A.S.	2010-10-07
K093825	AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE	Ambu A/S	2010-01-13
K091410	DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,	Spes Medica Srl	2009-08-11
K091055	RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R	Rhythmlink International, LLC	2009-06-23
K091056	RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R	Rhythmlink International, LLC	2009-06-23
K080914	ULTRASHARP CONCENTRIC NEEDLES	Rochester Electro Medical, Inc.	2008-07-15
K071186	MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE	Ambu A/S	2007-07-30
K062437	DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED	Technomed Europe	2007-02-16
K020907	NEUROLINE, SUBDERMAL NEEDLE ELECTRODES	Medicotest A/S	2002-06-14
K011818	STERILE EMG ELECTRODES	Nicolet Biomedical, Inc.	2001-09-06
K002992	DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431	Medtronic Functional Diagnostics A/S	2001-08-15
K001869	DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE	Medicotest A/S	2000-09-18
K982950	FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550	Chalgren Enterprises, Inc.	1999-06-22
K990015	ELECTRODE NEEDLES	Technomed Europe	1999-05-27
K990375	DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75	Medtronic Functional Diagnostics A/S	1999-03-09
K981004	SLE EMG ELECTRODES AND ACCESSORIES	Specialized Laboratory Equipment, Ltd.	1998-10-21
K973529	NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES	Medicotest A/S	1997-11-20
K973442	TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES	Medelec, Inc. D.B.A. Teca Corp.	1997-11-20
K973444	TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES	Medelec, Inc. D.B.A. Teca Corp.	1997-11-20
K961013	DISPOSABLE NEEDLE ELECTRODE	Medelec Intl. Corp.	1996-12-20
K960591	RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP	Chalgren Enterprises, Inc.	1996-06-13
K955335	DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE	Chalgren Enterprises, Inc.	1996-01-29

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08718375861707	Technomed Europe	Technomed Engineering B.V.	2019-11-21
08033315122312	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122688	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122664	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122640	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122626	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122602	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122589	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122565	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122466	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122442	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122411	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122398	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122374	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122350	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122336	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122541	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08033315122299	BIONEN	BIONEN SAS DI BARBARA NENCIONI & C.	2018-09-04
08718375861738	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861721	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861714	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375861653	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375860946	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375860939	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375860922	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375860915	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375860908	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375860892	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375860885	Technomed Europe	Technomed Engineering B.V.	2016-09-22
08718375860878	Technomed Europe	Technomed Engineering B.V.	2016-09-22

Product code IKT

Related 510(k) Records#

Related GUDID Devices#