BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BIOPSY ATTACHMENT

    K Number: K831317 · Decision May 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    42
    Review Days
    26

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    Basic Information

    Device Name
    BIOPSY ATTACHMENT
    K Number
    K831317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Diasonics, Inc.
    Date Received
    April 22, 1983
    Decision Date
    May 18, 1983
    Product Code
    FCI
    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
    FCI Punch, Biopsy

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