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510(k) Data Aggregation

    K Number
    K051281
    Device Name
    THE NEEDLE CATCHER
    Manufacturer
    E.D.MEDICAL LTD.
    Date Cleared
    2005-09-08

    (114 days)

    Product Code
    HTD
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    HTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Needlecatcher is designed for grasping suture needles during suturing and holding them during transport throughout the operating theatre.
    Device Description
    The Needle Catcher ™ is a stainless steel needle grasping instrument for use in suturing tissue to allow both tissue retaining and needle grasping in the same instrument. The Needle Catcher ™ uses a piston and cylinder assembly to grasp and hold the needle safely during knot tying.
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    K Number
    K974593
    Device Name
    SEMKIN INSULATED BIPOLAR FORCEP
    Manufacturer
    TITAN MFG., INC.
    Date Cleared
    1998-06-24

    (197 days)

    Product Code
    HTDGEI
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    HTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).
    Device Description
    Semkin Insulated Bipolar Forcep
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    K Number
    K974594
    Device Name
    SEMKIN BIPOLAR FORCEP
    Manufacturer
    TITAN MFG., INC.
    Date Cleared
    1998-06-24

    (197 days)

    Product Code
    HTDGEI
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    HTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).
    Device Description
    Semkin Bipolar Forcep
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    K Number
    K974595
    Device Name
    CUSHING BAYONET, INSULATED BIPOLAR FORCEP
    Manufacturer
    TITAN MFG., INC.
    Date Cleared
    1998-06-24

    (197 days)

    Product Code
    HTDGEI
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    HTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).
    Device Description
    Titan Cushing Bayonet Insulated Bipolar Forcep
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