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510(k) Data Aggregation

    K Number
    K173815
    Device Name
    Allergan Botox Needle Electrode
    Manufacturer
    Natus Manufacturing Limited
    Date Cleared
    2018-06-29

    (196 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Product Code :

    IKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Allergan Botox Needle Electrode are for SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.
    Device Description
    The Allergan Botox Needle Electrode is used in EMG applications to record EMG activity while allowing injection of medication. The Allergan Botox Needle Electrode is a sterile, disposable, monopolar needle electrode with attached lead wire. The needle shaft is insulated so the needle records signals received only from the tip. The needle hub is designed to allow for precise manipulation of the electrode.
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    K Number
    K161430
    Device Name
    Myoject Luer Lock Needle Electrode
    Manufacturer
    Natus Manufacturing Limited
    Date Cleared
    2017-03-02

    (283 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Product Code :

    IKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.
    Device Description
    The Myoject™ Luer Lock Needle Electrode is a Disposable Hypodermic Needle Electrode
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    K Number
    K152984
    Device Name
    Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2016-06-03

    (238 days)

    Product Code
    IKT, GXZ
    Regulation Number
    890.1385
    Why did this record match?
    Product Code :

    IKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only. Disposable Monopolar Needle electrodes / EP Needle electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only. Disposable Hypodermic Needle electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only.
    Device Description
    The Bio Protech Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. Bio Protech Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of silver. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant. The Bio Protech Disposable Monopolar / EP Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography / Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage. The Bio Protech Disposable Hypodermic Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
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    K Number
    K143433
    Device Name
    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
    Manufacturer
    Natus Manufacturing Limited
    Date Cleared
    2015-08-28

    (270 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Product Code :

    IKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dantec™ DCN Disposable Concentric Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
    Device Description
    The Dantec™ DCN Disposable Concentric Needle Electrodes are designed as an electrical bipolar recording device for use in electromyography. The Dantec™ DCN Disposable Concentric Needle Electrode consists of an insulated core wire located inside a stainless steel cannula. The hub has a raised bevel indicator, allowing the user to always know the direction of the recording surface. A coaxial hub allows easy connection between needle and the electrode cable.
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    K Number
    K120342
    Device Name
    EMG RECORDING ELECTRODE ASSEMBLY
    Manufacturer
    RHYTHMLINK INTERNATIONAL, LLC
    Date Cleared
    2012-06-22

    (140 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Product Code :

    IKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K112034
    Device Name
    TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
    Manufacturer
    CAREFUSION 209, INC.
    Date Cleared
    2011-08-12

    (28 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Product Code :

    IKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TECA™ ELITE Disposable Concentric Needles are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
    Device Description
    CareFusion 209, Inc. TECATM ELITE Disposable Concentric Needles (TECATM ELITE Needles) are disposable, single use, sterile products intended to sense subcutaneous bioelectrical activity, or to stimulate nerve or muscular response by insertion into the patients muscle(s) through the skin where the recording area can differentiate between individual motor units. TECATM ELITE Needles are connected to an electromyographic (EMG) device through a cable. The EMG device detects and displays the biopotential information to the user. TECATM ELITE Needles consist of a stainless steel tube with a conductive core. A polyesterimide isolative coating resides between the core and the stainless steel tube. The exterior surface of the needle is dipped in a low-friction lubricant. TECATM ELITE Needles are passive devices, and do not contain electrical hardware components or software. The following device modifications were made to the TECATM ELITE Needles: Modification of the core material; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the packaging materials.
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    K Number
    K111131
    Device Name
    TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
    Manufacturer
    CAREFUSION 209, INC.
    Date Cleared
    2011-06-17

    (57 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Product Code :

    IKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TECA™ elite Disposable Monopolar Needles are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
    Device Description
    CareFusion TECAT™ elite Disposable Monopolar Needles (TECATM elite Needles) are disposable, single use, sterile products intended to sense subcutaneous bioelectrical activity, or to stimulate nerve or muscular response by insertion into the patients muscle(s) through the skin where the recording area can differentiate between individual motor units. TECATM elite Needles are connected to an electromyographic (EMG) device through a cable. The EMG device detects and displays the biopotential information to the user. TECAT™ elite Needles are stainless steel, platinum alloy, and/or gold plated stainless steel, and coated with a polytetrafluoroethylene (PTFE) insulator. A low-friction lubricant is applied to the exterior surface of the needle. TECAT™ elite Needles are passive devices, and do not contain electrical hardware components or software. The following device modifications were made to the TECAT™ elite Needles: Reformulation of the PTFE exterior needle coating; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the needle tip geometry.
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    K Number
    K092973
    Device Name
    DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
    Manufacturer
    BIONEN S.A.S.
    Date Cleared
    2010-10-07

    (377 days)

    Product Code
    IKT, GXZ
    Regulation Number
    890.1385
    Why did this record match?
    Product Code :

    IKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) applications. The electrodes are for single patient use only. The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro - myography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only. The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.
    Device Description
    The BIONEN Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. BIONEN Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of stainless steel or platinum. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant. The BIONEN Disposable Monopolar/Subdermal Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography/Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage. The BIONEN Disposable Monopolar Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
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    K Number
    K093825
    Device Name
    AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
    Manufacturer
    AMBU A/S
    Date Cleared
    2010-01-13

    (30 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Product Code :

    IKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electromyography (EMG) Needle Electrode designed for Botulinum Toxin therapy and nerve block procedures. For single patient use only.
    Device Description
    The Ambu Neuroline Disposable Inoject needle electrode is a Single Patient needle electrode for Electromyography (EMG) guided injections. The needle electrode is designed for Botulinum Toxin therapy and nerve block procedures. The Ambu Neuroline Disposable Inoject needle is manufactured in different lengths and diameters. The Ambu Neuroline Disposable Inoject needle is connected to the EMG equipment through a touch proof connector with a pre-attached cable. The Ambu Neuroline Disposable Inoject needle electrode is a sterile product. Ambu Neuroline Disposable Inoject needle electrodes consist of a coated needle made from stainless steel. The Ambu Neuroline Disposable Inoject needle electrode is used with a reference electrode and a ground electrode.
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    K Number
    K091410
    Device Name
    DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
    Manufacturer
    SPES MEDICA S.R.L.
    Date Cleared
    2009-08-11

    (90 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Product Code :

    IKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Recording muscle activity for Electromyography (EMG) applications. For single patient use only. The disposable hypodermic needle is inteded to be used for iniection of the Botulinum Toxin into a muscle. while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.
    Device Description
    A diagnostic electromyography needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle). The needle electrodes are for single patient only.
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