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

    Single-use Video Scope; PB Digital Controller

    K Number: K254153 · Decision Apr 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    42
    Applicant Total
    5
    Review Days
    102

    Basic Information

    Device Name
    Single-use Video Scope; PB Digital Controller
    K Number
    K254153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mirco-Tech (Nanjing) Co., Ltd.
    Date Received
    December 22, 2025
    Decision Date
    April 3, 2026
    Product Code
    FBN
    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
    FBN Choledochoscope And Accessories, Flexible/Rigid

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