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

    ACCORDION

    K Number: K052048 · Decision Sep 13, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    51
    Applicant Total
    5
    Review Days
    46

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    Basic Information

    Device Name
    ACCORDION
    K Number
    K052048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Percutaneous Systems, Incorporated
    Date Received
    July 29, 2005
    Decision Date
    September 13, 2005
    Product Code
    FFL
    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
    FFL Dislodger, Stone, Basket, Ureteral, Metal

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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
    K052298 CYSTOGLIDE INTRODUCER SHEATH
    K042531 UPDATED SLIP UROLOGY INTRODUCER SHEATH