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

    Ranfac Cartilage Biopsy Needle

    K Number: K183146 · Decision Apr 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    198
    Registration Numbers
    198
    Same Product Code
    353
    Applicant Total
    4
    Review Days
    163

    Basic Information

    Device Name
    Ranfac Cartilage Biopsy Needle
    K Number
    K183146
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ranfac Corporation
    Date Received
    November 13, 2018
    Decision Date
    April 25, 2019
    Product Code
    KNW
    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
    KNW Instrument, Biopsy

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