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    K Number
    K984434
    Device Name
    MEDIVISION LAPAROSCOPE
    Manufacturer
    MEDIVISION SCOPE SERVICE CENTER, INC.
    Date Cleared
    1999-03-17

    (93 days)

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

    MEDIVISION SCOPE SERVICE CENTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic, procedures such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The laparoscope may be attached to hand --held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The laparoscope is designed to pass through standard laparoscopic and thoracoscopic 10mm cannulas to gain access to the subject surgical site.
    Device Description
    Not Found
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    K Number
    K982659
    Device Name
    MEDIVISION HYSTEROSCOPE
    Manufacturer
    MEDIVISION SCOPE SERVICE CENTER, INC.
    Date Cleared
    1998-10-07

    (69 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIVISION SCOPE SERVICE CENTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MEDIVISION HYSTEROSCOPE MV400/MV415/MV430/MV470 INDICATIONS for USE NOTE: Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery. Diagnostic Hysteroscopy - . Abnormal Uterine Bleeding - Infertility & Pregnancy Wastage . - Evaluation of Abnormal Hysterosalpingogram # - Intrauterine Foreign Body - . Amenontiea - Pelvic Pain . - Operative Hysteroscopy - . Directed Blopsy - Removal of Submucous Fibroids and Large Polyps . - . Submucous Myomectorny - . Transection of Intrauterine Adhesions - o Transection of Intrauterine Septa - . Endometrial Ablation Medical disease, cervical stenosis, and pelvic infection may alter the choice of location for hysteroscopy {i.e., office setting vs. Hospital),
    Device Description
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    K Number
    K982620
    Device Name
    MEDIVISION CYSTOSCOPE
    Manufacturer
    MEDIVISION SCOPE SERVICE CENTER, INC.
    Date Cleared
    1998-09-30

    (65 days)

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

    MEDIVISION SCOPE SERVICE CENTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use for the MediVision Cystoscope are as follows: MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. This device is marketed as a reusable device; methods for cleaning, disinfecting, and sterilization are included in latter sections of this submission under Section 5, STERILIZATION INFORMATION.
    Device Description
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    K Number
    K971996
    Device Name
    MEDIVISION ARTHROSCOP
    Manufacturer
    MEDIVISION SCOPE SERVICE CENTER, INC.
    Date Cleared
    1997-07-31

    (62 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIVISION SCOPE SERVICE CENTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K971995
    Device Name
    MEDIVISION SINOSCOPE
    Manufacturer
    MEDIVISION SCOPE SERVICE CENTER, INC.
    Date Cleared
    1997-06-26

    (27 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIVISION SCOPE SERVICE CENTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended use for the MediVision Sinoscope is to allow direct visualization through the sinoscope or the video monitor of the nasal cavity.
    Device Description
    Not Found
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