BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    LAPARETTE, MODEL LAP J L S H N

    K Number: K022979 · Decision Dec 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    43
    Applicant Total
    2
    Review Days
    100

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    Basic Information

    Device Name
    LAPARETTE, MODEL LAP J L S H N
    K Number
    K022979
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instruments Medicaux G.B., Inc.
    Date Received
    September 9, 2002
    Decision Date
    December 18, 2002
    Product Code
    KNF
    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
    KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

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    Other Clearances by Instruments Medicaux G.B., Inc.

    K Number Device Name
    K010220 XTRACTOR, MODEL M143