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

    THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200

    K Number: K010283 · Decision Apr 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200
    K Number
    K010283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Theragenics Corp.
    Date Received
    January 30, 2001
    Decision Date
    April 26, 2001
    Product Code
    KXK
    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
    KXK Source, Brachytherapy, Radionuclide

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    Other Clearances by Theragenics Corp.

    K Number Device Name
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    K043596 THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
    K874787 MODIFIED PALLADIUM SEED MODEL 100