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

    Biliary Pancreaticobiliary Scope System

    K Number: K241444 · Decision Jan 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    42
    Applicant Total
    8
    Review Days
    244

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    Basic Information

    Device Name
    Biliary Pancreaticobiliary Scope System
    K Number
    K241444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen HugeMed Medical Technical Development Co., Ltd.
    Date Received
    May 22, 2024
    Decision Date
    January 21, 2025
    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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    Other Clearances by Shenzhen HugeMed Medical Technical Development Co., Ltd.

    K Number Device Name
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