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

    Disposable Stone Extraction Basket

    K Number: K253056 · Decision Apr 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    37
    Applicant Total
    5
    Review Days
    193

    Basic Information

    Device Name
    Disposable Stone Extraction Basket
    K Number
    K253056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Soudon Medical Technology Co., Ltd.
    Date Received
    September 22, 2025
    Decision Date
    April 3, 2026
    Product Code
    LQR
    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
    LQR Dislodger, Stone, Biliary

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