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

    Visualized Access and Delivery Catheter; PB Digital Controller

    K Number: K252492 · Decision Apr 24, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    41
    Review Days
    259

    Basic Information

    Device Name
    Visualized Access and Delivery Catheter; PB Digital Controller
    K Number
    K252492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Tech (Nanjing) Co., Ltd.
    Date Received
    August 8, 2025
    Decision Date
    April 24, 2026
    Product Code
    SHU
    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
    SHU Appendiceal Scope And Accessories, Flexible

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