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

    INTRODUCER SHEATH

    K Number: K001328 · Decision Jul 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    82

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    Basic Information

    Device Name
    INTRODUCER SHEATH
    K Number
    K001328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Novasys Medical, Inc.
    Date Received
    April 26, 2000
    Decision Date
    July 17, 2000
    Product Code
    FEC
    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
    FEC Obturator, For Endoscope

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