BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇺 Australia

    ASPIRATING AND IRRIGATING CYSTS NEEDLES

    K Number: K885283 · Decision Mar 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    47
    Applicant Total
    11
    Review Days
    92

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    Basic Information

    Device Name
    ASPIRATING AND IRRIGATING CYSTS NEEDLES
    K Number
    K885283
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Go Medical Industries Pty. , Ltd.
    Date Received
    December 20, 1988
    Decision Date
    March 22, 1989
    Product Code
    GDM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GDM Needle, Aspiration And Injection, Reusable

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