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

    MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE

    K Number: K972926 · Decision Oct 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    42
    Applicant Total
    334
    Review Days
    61

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    Basic Information

    Device Name
    MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
    K Number
    K972926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    August 8, 1997
    Decision Date
    October 8, 1997
    Product Code
    FBN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FBN Choledochoscope And Accessories, Flexible/Rigid

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