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510(k) Data Aggregation

    K Number
    K201279
    Device Name
    ASSISTO Universal Applicator Clamping Device
    Manufacturer
    Geomed Medizin-Technik GmbH & Co. KG
    Date Cleared
    2020-07-10

    (58 days)

    Product Code
    JAQ, GCJ, GWG
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Geomed Medizin-Technik GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASSISTO® Universal Applicator Clamping Device is indicated for use as an accessory for HDR or PDR brachytherapy treatment. Specifically, it is intended to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy.
    Device Description
    The ASSISTO® Universal Applicator Clamping Device is a self-retaining device that consists of a stainless steel tubular, articulated arm connected to a vertical stand. The arm is freely adjustable within the articulating radius. A screw clamp mounted on the distal end of the device serves to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vagina, vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy. Two accessories, a stainless steel clamp socket and a base plate manufactured of thermoplastic and stainless steel, are provided to table-mount the device during clinical use. The ASSISTO® Universal Applicator Clamping Device and the clamp socket are reusable and provided non-sterile for cleaning and sterilization by the user before use. The non-sterile, reusable base plate is intended for cleaning and disinfection by the user before use.
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    K Number
    K183438
    Device Name
    Geomed Vascular Dilators
    Manufacturer
    Geomed Medizin-Technik GmbH & Co.
    Date Cleared
    2019-09-03

    (265 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Geomed Medizin-Technik GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
    Device Description
    Vascular Dilators are reusable stainless-steel surgical instruments that are used by qualified surgeons to enlarge or calibrate vessels. They are provided in two basic models and various sizes to accommodate individual needs, based on the anatomy of the site and the type of surgical procedure. The device is provided non-sterile for steam sterilization by the user.
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    K Number
    K052745
    Device Name
    ASSISTO ARM SYSTEMS
    Manufacturer
    GEOMED MEDIZIN-TECHNIK GMBH & CO.
    Date Cleared
    2005-11-23

    (54 days)

    Product Code
    GWG, GCJ
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    **GEOMED MEDIZIN-TECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.
    Device Description
    Table-mounted self-retaining endoscope holder system consisting of stainless steel tubular, articulated arms that are connected to a vertical stand and are freely adjustable within the articulating radius according to the requirements of the particular surgical procedure. Accessories include endoscope holders for 2.7mm to 10mm scopes. The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
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