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

    A LITHOTRIPTER-COMPATIBLE BASKET

    K Number: K964937 · Decision Jan 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    10
    Applicant Total
    432
    Review Days
    45

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    Basic Information

    Device Name
    A LITHOTRIPTER-COMPATIBLE BASKET
    K Number
    K964937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    December 10, 1996
    Decision Date
    January 24, 1997
    Product Code
    LQC
    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
    LQC Lithotriptor, Biliary Mechanical

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