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510(k) Data Aggregation

    K Number
    K970937
    Device Name
    MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)
    Manufacturer
    Date Cleared
    1997-09-26

    (197 days)

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

    MIST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MIST Micro Interchangeable Scope System ™ is intended to be used by trained physicians for the illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures. The MIST Micro Interchangeable Scope Systems are rigid, two piece fiber-optic endoscopes intended for the illumination and direct visualization of body cavities, hollow organs and canals during general diagnostic procedures.
    Device Description
    The MIST Micro Interchangeable Scope System ™ is a two piece, rigid, fiberoptic laparoscope. The universal eyepiece (MicroView Handle)) may be used with several variable sizes of shafts. No working channel is provided. The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.
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    K Number
    K971150
    Device Name
    MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE
    Manufacturer
    Date Cleared
    1997-09-23

    (179 days)

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

    MIST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MIST Panoramic Laparoscope is intended to be used by trained physicians for the illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures. The MIST Panoramic Laparoscope is a rigid laparoscope intended for the illumination and direct visualization of body cavities, hollow organs and canals for the purpose of diagnosis of diseases and/or minimally invasive general surgeries.
    Device Description
    The MIST Panoramic Laparoscope is a rigid, fiber-optic laparoscope. No working channel is provided. The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.
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    Ask a specific question about this device

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