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

    Modulith SLX-F2

    K Number: K201001 · Decision Mar 30, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    55
    Applicant Total
    5
    Review Days
    348

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    Basic Information

    Device Name
    Modulith SLX-F2
    K Number
    K201001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5990
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz Endoscopy America
    Date Received
    April 16, 2020
    Decision Date
    March 30, 2021
    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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