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

    SHARGHP A.V. FISTULA NEEDLE SET

    K Number: K013384 · Decision Jan 7, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    78
    Applicant Total
    5
    Review Days
    87

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    Basic Information

    Device Name
    SHARGHP A.V. FISTULA NEEDLE SET
    K Number
    K013384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shargh Pharmaceutical Co., Inc.
    Date Received
    October 12, 2001
    Decision Date
    January 7, 2002
    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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    Other Clearances by Shargh Pharmaceutical Co., Inc.

    K Number Device Name
    K895812 SHARGHP INTRAVENOUS CATHETER
    K895980 SHARGHP INSULIN SYRINGES
    K895811 SHARGHP HYPODERMIC NEEDLE
    K895810 SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE