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

    VARI-PASS VARIABLE LENGTH ACCESS SHEATH

    K Number: K123170 · Decision Feb 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    12
    Review Days
    118

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    Basic Information

    Device Name
    VARI-PASS VARIABLE LENGTH ACCESS SHEATH
    K Number
    K123170
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Surgical Technologies America
    Date Received
    October 9, 2012
    Decision Date
    February 4, 2013
    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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