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

    NORTEC URETERAL STENT

    K Number: K910691 · Decision Aug 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    16
    Review Days
    177

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    Basic Information

    Device Name
    NORTEC URETERAL STENT
    K Number
    K910691
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    North American Sterilization & Packaging Co.
    Date Received
    February 19, 1991
    Decision Date
    August 15, 1991
    Product Code
    FAD
    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
    FAD Stent, Ureteral

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    Other Clearances by North American Sterilization & Packaging Co.

    K Number Device Name
    K964231 NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
    K963753 NASP TRANSPARENT DRESSING
    K962352 HYDROGEL SKIN DRESSING
    K925588 NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
    K925593 NORTEC STERILE WATER FOR DEVICE IRRIGATION
    K925161 NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
    K911865 NORTEC CONNECTING TUBE SET
    K911784 NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
    K903162 FLEXIBLE ENDOSCOPIC ELECTRODES
    K903156 CONTROL-TIP CYSTOSCOPIC ELECTRODES
    Search all 16 clearances from North American Sterilization & Packaging Co. →