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

    B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE

    K Number: K950982 · Decision Apr 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    19
    Review Days
    32

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    Basic Information

    Device Name
    B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
    K Number
    K950982
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B. Braun of America, Inc.
    Date Received
    March 3, 1995
    Decision Date
    April 4, 1995
    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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