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

    Yarlap II

    K Number: K160773 · Decision May 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    4
    Review Days
    44

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    Basic Information

    Device Name
    Yarlap II
    K Number
    K160773
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Trade Group, Inc.
    Date Received
    March 21, 2016
    Decision Date
    May 4, 2016
    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 International Trade Group, Inc.

    K Number Device Name
    K171092 XiniWave II Model ECS322P
    K141643 YARLAP
    K100441 XINIWAVE, MODEL XW-18