FDA 510(k) Applications for Medical Device Product Code "IKT"
(Electrode, Needle, Diagnostic Electromyograph)

FDA 510(k) Number Applicant Device Name Decision Date
K093825 AMBU A/S AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE 01/13/2010
K071186 AMBU A/S MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE 07/30/2007
K152984 BIO PROTECH, INC. Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes 06/03/2016
K092973 BIONEN S.A.S. DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE 10/07/2010
K111131 CAREFUSION 209, INC. TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES 06/17/2011
K112034 CAREFUSION 209, INC. TECA ELITE DISPOSABLE CONCENTRIC NEEDLES 08/12/2011
K955335 CHALGREN ENTERPRISES, INC. DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE 01/29/1996
K982950 CHALGREN ENTERPRISES, INC. FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 06/22/1999
K960591 CHALGREN ENTERPRISES, INC. RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP 06/13/1996
K961013 MEDELEC INTL. CORP. DISPOSABLE NEEDLE ELECTRODE 12/20/1996
K973442 MEDELEC, INC. D.B.A. TECA CORP. TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES 11/20/1997
K973444 MEDELEC, INC. D.B.A. TECA CORP. TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES 11/20/1997
K001869 MEDICOTEST A/S DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE 09/18/2000
K973529 MEDICOTEST A/S NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES 11/20/1997
K020907 MEDICOTEST A/S NEUROLINE, SUBDERMAL NEEDLE ELECTRODES 06/14/2002
K002992 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 08/15/2001
K990375 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 03/09/1999
K173815 Natus Manufacturing Limited Allergan Botox Needle Electrode 06/29/2018
K143433 Natus Manufacturing Limited 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 08/28/2015
K161430 Natus Manufacturing Limited Myoject Luer Lock Needle Electrode 03/02/2017
K011818 NICOLET BIOMEDICAL, INC. STERILE EMG ELECTRODES 09/06/2001
K120342 RHYTHMLINK INTERNATIONAL, LLC EMG RECORDING ELECTRODE ASSEMBLY 06/22/2012
K091055 RHYTHMLINK INTERNATIONAL, LLC RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R 06/23/2009
K091056 RHYTHMLINK INTERNATIONAL, LLC RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R 06/23/2009
K080914 ROCHESTER ELECTRO MEDICAL, INC. ULTRASHARP CONCENTRIC NEEDLES 07/15/2008
K981004 SPECIALIZED LABORATORY EQUIPMENT, LTD. SLE EMG ELECTRODES AND ACCESSORIES 10/21/1998
K091410 SPES MEDICA S.R.L. DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, 08/11/2009
K062437 TECHNOMED EUROPE DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED 02/16/2007
K990015 TECHNOMED EUROPE ELECTRODE NEEDLES 05/27/1999


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