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

    MANAN PROSTATIC BIOPSY NEEDLE

    K Number: K895897 · Decision Oct 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    39
    Review Days
    12

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    Basic Information

    Device Name
    MANAN PROSTATIC BIOPSY NEEDLE
    K Number
    K895897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Manan Medical Products, Inc.
    Date Received
    October 6, 1989
    Decision Date
    October 18, 1989
    Product Code
    FCG
    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
    FCG Biopsy Needle

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