BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Ureteral Guide Sheath

    K Number: K241181 · Decision Aug 2, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    107
    Registration Numbers
    107
    Same Product Code
    95
    Applicant Total
    2
    Review Days
    95

    Basic Information

    Device Name
    Disposable Ureteral Guide Sheath
    K Number
    K241181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dongguan ZSR Biomedical technology Company Limited
    Date Received
    April 29, 2024
    Decision Date
    August 2, 2024
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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    Other Clearances by Dongguan ZSR Biomedical technology Company Limited

    K Number Device Name
    K243155 Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)