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510(k) Data Aggregation

    K Number
    K142719
    Device Name
    E-App
    Manufacturer
    GC MEDTECH, LLC
    Date Cleared
    2015-05-20

    (239 days)

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

    GC MEDTECH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GC Medtech Esophageal Applicator (E-App) is an applicator used to facilitate delivery of a prescription of radiation to the esophagus when used in conjunction with a high dose rate after-loader.
    Device Description
    Not Found
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    K Number
    K133922
    Device Name
    GENTLECARE AR APPLICATOR
    Manufacturer
    GC MEDTECH, LLC
    Date Cleared
    2014-04-18

    (116 days)

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

    GC MEDTECH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GentleCare AR Applicator is Intended for use during brachytherapy procedures. The nultiple lumens of the GC MedTech device are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
    Device Description
    The GentleCare AR Applicator is a specialized applicator that is temporarily inserted into the vagina or rectum to facilitate the application of radiation to the target site in the treatment of carcinoma. The GentleCare AR Applicator is provided sterile for single use and is disposable.
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