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

    I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE

    K Number: K023242 · Decision Dec 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    6
    Review Days
    65

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    Basic Information

    Device Name
    I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
    K Number
    K023242
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Implant Sciences Corp.
    Date Received
    September 30, 2002
    Decision Date
    December 4, 2002
    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 Implant Sciences Corp.

    K Number Device Name
    K070468 IMPLANT SCIENCES CORP. MODEL HDR 4454
    K042864 IMPLANT SCIENCES CORP, MODEL HDR-4140
    K023073 SEED LINK
    K994317 I-PLANT, MODEL 3500
    K990193 IODINE BRACHYTHERAPY SEEDS, MODEL 3000