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

    Ensure Single-Use Coagulation Forceps

    K Number: K202438 · Decision Mar 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    45
    Applicant Total
    41
    Review Days
    202

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    Basic Information

    Device Name
    Ensure Single-Use Coagulation Forceps
    K Number
    K202438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Tech (Nanjing) Co., Ltd.
    Date Received
    August 25, 2020
    Decision Date
    March 15, 2021
    Product Code
    KGE
    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
    KGE Forceps, Biopsy, Electric

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