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510(k) Data Aggregation

    K Number
    K040949
    Device Name
    VIADUCT MINISCOPE AND ACCESSORIES
    Manufacturer
    ACUEITY, INC.
    Date Cleared
    2004-05-07

    (25 days)

    Product Code
    GCT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUEITY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic or graspilly son thisue not intended for therapeutic use.
    Device Description
    Like the predicate devices, the Acueity ViaDuct Miniscope and Accessories consist of a semi-rigid fiberscope with an irrigating outer sheath or introducer capable of passing a biopsy needle to a soft tissue site for view or, to view and assess/biopsy soft tissue. The Acueity ViaDuct Miniscope and Accessories is also designed with an inner grasping sheath or tube that can be placed within the outer introducer, which together act as forceps capable of grasping soft tissue for biopsy. The combination of these devices allows access to very finite spaces.
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    K Number
    K032847
    Device Name
    EXCISOR BIOPTOME, MODEL 01-0004
    Manufacturer
    ACUEITY, INC.
    Date Cleared
    2003-09-26

    (14 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUEITY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acueity Excisor Bioptome is a multiple action biopsy system intended for obtaining a soft tissue breast biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.
    Device Description
    The Excisor Bioptome is a percutaneous, mechanical coring device utilizing imaging quidance such as ultrasound and X-ray for breast biopsy. The basic structure of the device includes a Motorized Cutter and detachable stainless steel Introducer with aluminum handle or finger piece and aspiration port and a stainless steel trocar.
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    K Number
    K032430
    Device Name
    ACUEITY MEDICAL LIGHT SOURCE
    Manufacturer
    ACUEITY, INC.
    Date Cleared
    2003-09-05

    (30 days)

    Product Code
    FCW
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUEITY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acueity Medical Light Source is indicated for use in illuminating the operative site and providing video images that can be displayed on a monitor. The device is designed for attachment to endoscopes and laparoscopes that are used in medical procedures.
    Device Description
    The Medical Light Source was specifically designed for medical applications. Therefore, the highest safety requirements for the patient as well as for the physician are applied. The Light Source combines highest illumination requirements with high-resolution video capabilities through an integrated highresolution ¼", ½" or 1/3" CCD camera board.
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    K Number
    K011189
    Device Name
    VIADUCT MICROENDOSCOPE AND ACCESSORIES
    Manufacturer
    ACUEITY, INC.
    Date Cleared
    2001-07-16

    (89 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUEITY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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