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

    CONTROL-TIP CYSTOSCOPIC ELECTRODES

    K Number: K903156 · Decision Dec 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    16
    Review Days
    153

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    Basic Information

    Device Name
    CONTROL-TIP CYSTOSCOPIC ELECTRODES
    K Number
    K903156
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    North American Sterilization & Packaging Co.
    Date Received
    July 18, 1990
    Decision Date
    December 18, 1990
    Product Code
    FAS
    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
    FAS Electrode, Electrosurgical, Active, Urological

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    Other Clearances by North American Sterilization & Packaging Co.

    K Number Device Name
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    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
    K910691 NORTEC URETERAL STENT
    K903162 FLEXIBLE ENDOSCOPIC ELECTRODES
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