BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    VIRTUAL PORTS ENDOCLEAR SYSTEM

    K Number: K080051 · Decision Mar 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    VIRTUAL PORTS ENDOCLEAR SYSTEM
    K Number
    K080051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Virtual Ports, Ltd.
    Date Received
    January 8, 2008
    Decision Date
    March 21, 2008
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Virtual Ports, Ltd.

    K Number Device Name
    K100346 ENDOCLEAR SYSTEM