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

    ENCLOSE II ANASTOMOSIS ASSIST DEVICE

    K Number: K032589 · Decision Sep 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    9
    Review Days
    14

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    Basic Information

    Device Name
    ENCLOSE II ANASTOMOSIS ASSIST DEVICE
    K Number
    K032589
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novare Surgical Systems, Inc.
    Date Received
    August 22, 2003
    Decision Date
    September 5, 2003
    Product Code
    DXC
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXC Clamp, Vascular

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    Other Clearances by Novare Surgical Systems, Inc.

    K Number Device Name
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    K010694 INCLUDER CLAMP
    K992980 ENGAGE JAW INSERTS
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