BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)

    K Number: K960400 · Decision Mar 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    8
    Applicant Total
    10
    Review Days
    43

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    Basic Information

    Device Name
    DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
    K Number
    K960400
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Snowden-Pencer
    Date Received
    January 29, 1996
    Decision Date
    March 12, 1996
    Product Code
    FBM
    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
    FBM Cannula And Trocar, Suprapubic, Non-Disposable

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