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

    URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12

    K Number: K061333 · Decision Jul 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    52

    Basic Information

    Device Name
    URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
    K Number
    K061333
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5310
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    UROPLASTY, INC.
    Date Received
    May 12, 2006
    Decision Date
    July 3, 2006
    Product Code
    NAM
    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
    NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

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    Other Clearances by UROPLASTY, INC.

    K Number Device Name
    K121337 UROPLASTY RIGID ENDOSCPIC NEEDLES
    K101847 URGENT PC STIMULATOR; URGENT PC LEAD SET
    K091391 UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
    K071822 URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
    K052025 URGENT PC NEUROMODULATION SYSTEM
    K052175 I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
    K051905 UROPLASTY RIGID ENDOSCOPIC NEEDLE