BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    LAPORT

    K Number: K092584 · Decision Mar 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    210

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    Basic Information

    Device Name
    LAPORT
    K Number
    K092584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mgb Endoskopische Gerate GmbH (Berlin)
    Date Received
    August 24, 2009
    Decision Date
    March 22, 2010
    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 Mgb Endoskopische Gerate GmbH (Berlin)

    K Number Device Name
    K093194 MGB DISPOSABLE RETRIEVAL BAG LAPBAG
    K032545 ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250
    K032544 VP-1000; MED CAM 100; VP-3000A; MED CAM 300