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

    FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS

    K Number: K023162 · Decision Mar 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    78
    Applicant Total
    7
    Review Days
    178

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    Basic Information

    Device Name
    FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
    K Number
    K023162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care
    Date Received
    September 23, 2002
    Decision Date
    March 20, 2003
    Product Code
    FIE
    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
    FIE Needle, Fistula

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