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

    MODULTH SLK

    K Number: K120769 · Decision Jun 12, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    55
    Applicant Total
    334
    Review Days
    90

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    Basic Information

    Device Name
    MODULTH SLK
    K Number
    K120769
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5990
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    March 14, 2012
    Decision Date
    June 12, 2012
    Product Code
    LNS
    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
    LNS Lithotriptor, Extracorporeal Shock-Wave, Urological

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