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

    MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS

    K Number: K883189 · Decision Feb 13, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    334
    Review Days
    200

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    Basic Information

    Device Name
    MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
    K Number
    K883189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4480
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    July 28, 1988
    Decision Date
    February 13, 1989
    Product Code
    FFK
    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
    FFK Lithotriptor, Electro-Hydraulic

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