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

    Blue Beacon Submucosal Injectable Solution

    K Number: K200071 · Decision Nov 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    41
    Review Days
    295

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    Basic Information

    Device Name
    Blue Beacon Submucosal Injectable Solution
    K Number
    K200071
    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
    January 13, 2020
    Decision Date
    November 3, 2020
    Product Code
    PLL
    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
    PLL Submucosal Injection Agent

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