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

    INTRAUTERINE DELIVERY SYSTEM - INJECTOR

    K Number: K023051 · Decision Dec 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    86
    Applicant Total
    16
    Review Days
    90

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    Basic Information

    Device Name
    INTRAUTERINE DELIVERY SYSTEM - INJECTOR
    K Number
    K023051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Prosurg, Inc.
    Date Received
    September 13, 2002
    Decision Date
    December 12, 2002
    Product Code
    LKF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKF Cannula, Manipulator/Injector, Uterine

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