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

    CYSTOGLIDE INTRODUCER SHEATH

    K Number: K052298 · Decision Dec 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    5
    Review Days
    476

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    Basic Information

    Device Name
    CYSTOGLIDE INTRODUCER SHEATH
    K Number
    K052298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Percutaneous Systems, Incorporated
    Date Received
    August 23, 2005
    Decision Date
    December 12, 2006
    Product Code
    KNY
    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
    KNY Accessories, Catheter, G-U

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    Other Clearances by Percutaneous Systems, Incorporated

    K Number Device Name
    K090485 COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
    K061766 EXPRESSWAY INTERMITTENT CATHETER
    K052048 ACCORDION
    K042531 UPDATED SLIP UROLOGY INTRODUCER SHEATH