BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    F88 URE-SD/RD Flexible Ureteroscope

    K Number: K243894 · Decision May 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    1
    Review Days
    135

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    Basic Information

    Device Name
    F88 URE-SD/RD Flexible Ureteroscope
    K Number
    K243894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sg Endoscopy Pte, Ltd.
    Date Received
    December 18, 2024
    Decision Date
    May 2, 2025
    Product Code
    FGB
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

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