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

    Biopsy Needle

    K Number: K191472 · Decision Jan 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    2
    Review Days
    240

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    Basic Information

    Device Name
    Biopsy Needle
    K Number
    K191472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ushare Medical, Inc.
    Date Received
    June 3, 2019
    Decision Date
    January 29, 2020
    Product Code
    FCG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCG Biopsy Needle

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