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510(k) Data Aggregation

    K Number
    K203141
    Device Name
    Uramix CuraWay Biopsy Needle
    Manufacturer
    Uramix, Inc.
    Date Cleared
    2021-09-17

    (332 days)

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

    Uramix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Uramix Curaway Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidneys, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone, or breast.
    Device Description
    The URAMIX CuraWay Automatic Core Biopsy Instrument is a single use only core biopsy device and is individually packaged and sterilized. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified to maintain the sterilization condition of the device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color coded according to the various gauge sizes. The 18 gauge is the one used for current intended marketing, for prostate and kidney biopsies.
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