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

    ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI

    K Number: K932115 · Decision Jun 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    86
    Applicant Total
    2
    Review Days
    417

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    Basic Information

    Device Name
    ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI
    K Number
    K932115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Blairden Precision Instruments, Inc.
    Date Received
    May 3, 1993
    Decision Date
    June 24, 1994
    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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    Other Clearances by Blairden Precision Instruments, Inc.

    K Number Device Name
    K912761 SURGICAL SAW BLADES