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

    A.V. FISTULA NEEDLE

    K Number: K001496 · Decision Aug 1, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    78
    Applicant Total
    7
    Review Days
    78

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    Basic Information

    Device Name
    A.V. FISTULA NEEDLE
    K Number
    K001496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Exelint International, Co.
    Date Received
    May 15, 2000
    Decision Date
    August 1, 2000
    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 Exelint International, Co.

    K Number Device Name
    K251089 EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
    K152183 EXELINT SecureTouch Safety Hypodermic Needle
    K101309 EXELINT ALUMINUM HUB BLUNT NEEDLES
    K020189 EXEL BUTTERFLY SCALP VEIN SET
    K010197 EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
    K003627 EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET