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

    MEDIVISION LAPAROSCOPE

    K Number: K984434 · Decision Mar 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    93

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    Basic Information

    Device Name
    MEDIVISION LAPAROSCOPE
    K Number
    K984434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medivision Scope Service Center, Inc.
    Date Received
    December 14, 1998
    Decision Date
    March 17, 1999
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Medivision Scope Service Center, Inc.

    K Number Device Name
    K982659 MEDIVISION HYSTEROSCOPE
    K982620 MEDIVISION CYSTOSCOPE
    K971996 MEDIVISION ARTHROSCOP
    K971995 MEDIVISION SINOSCOPE