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

    UROSTYM BIOFEEDBACK AND STIMULATION PROBES

    K Number: K990041 · Decision Aug 5, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    5
    Review Days
    211

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    Basic Information

    Device Name
    UROSTYM BIOFEEDBACK AND STIMULATION PROBES
    K Number
    K990041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laborie Medical Tech Corp.
    Date Received
    January 6, 1999
    Decision Date
    August 5, 1999
    Product Code
    KPI
    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
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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    Other Clearances by Laborie Medical Tech Corp.

    K Number Device Name
    K993721 UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
    K991479 VISER PENILE TUMESCENCE MONITOR
    K963064 ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
    K950016 CART, MODE NUMBER UDS-CART