BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Percutaneous Nephroscope System

    K Number: K232370 · Decision May 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    9
    Applicant Total
    25
    Review Days
    267

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    Basic Information

    Device Name
    Percutaneous Nephroscope System
    K Number
    K232370
    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 SE & CO. KG
    Date Received
    August 8, 2023
    Decision Date
    May 1, 2024
    Product Code
    FGA
    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
    FGA Kit, Nephroscope

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