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

    IRIDIUM 192 WIRES

    K Number: K850163 · Decision Mar 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    31
    Review Days
    69

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    Basic Information

    Device Name
    IRIDIUM 192 WIRES
    K Number
    K850163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Syncor Intl. Corp.
    Date Received
    January 16, 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

    Similar 510(k) Clearances

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    Other Clearances by Syncor Intl. Corp.

    K Number Device Name
    K945825 SECURE SAFETY INSERT
    K851828 IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C
    K850433 CESIUM 137 ENDOMETRIAL SOURCE
    K852023 CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
    K852665 SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY
    K851033 SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
    K844735 PTH-RIA
    K850208 FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
    K850726 WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD
    K850434 CS137 SEALED SOURCES
    Search all 31 clearances from Syncor Intl. Corp. →