BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM

    K Number: K010166 · Decision Dec 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    35
    Applicant Total
    7
    Review Days
    319

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    Basic Information

    Device Name
    IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
    K Number
    K010166
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagyn Medical Technologies, Inc.
    Date Received
    January 18, 2001
    Decision Date
    December 3, 2001
    Product Code
    IWJ
    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
    IWJ System, Applicator, Radionuclide, Manual

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