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

    7 mm Extended Length Endoscope

    K Number: K191930 · Decision Apr 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    14
    Review Days
    271

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    Basic Information

    Device Name
    7 mm Extended Length Endoscope
    K Number
    K191930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maquet Cardiovascular, LLC
    Date Received
    July 19, 2019
    Decision Date
    April 15, 2020
    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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    K191947 VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord
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    K153523 FUSION Vascular Graft
    K132743 HARVESTING CANNULA
    K131778 FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
    K122612 HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
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