BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD

    K Number: K850726 · Decision Mar 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    31
    Review Days
    32

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    Basic Information

    Device Name
    WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD
    K Number
    K850726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Syncor Intl. Corp.
    Date Received
    February 22, 1985
    Decision Date
    March 26, 1985
    Product Code
    IWA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IWA Source, Wire, Iridium, Radioactive

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    Other Clearances by Syncor Intl. Corp.

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    K852023 CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
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    K851033 SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
    K844735 PTH-RIA
    K850163 IRIDIUM 192 WIRES
    K850208 FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
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