BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    SKYLARK URO PROBE

    K Number: K053007 · Decision Dec 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    6
    Review Days
    40

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    Basic Information

    Device Name
    SKYLARK URO PROBE
    K Number
    K053007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Skylark Device & Systems Co., Ltd.
    Date Received
    October 26, 2005
    Decision Date
    December 5, 2005
    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 Skylark Device & Systems Co., Ltd.

    K Number Device Name
    K050174 BIO-STIM KIT
    K043306 SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR
    K034005 SDS-4I
    K002832 CONDUCTIVE GEL FOR ULTRASOUND
    K992652 SD-730 IF-SDS, PERFECT PULSE IF-SDS