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

    BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034

    K Number: K082589 · Decision May 22, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    5
    Review Days
    256

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    Basic Information

    Device Name
    BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
    K Number
    K082589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Barosense, Inc.
    Date Received
    September 8, 2008
    Decision Date
    May 22, 2009
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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    Other Clearances by Barosense, Inc.

    K Number Device Name
    K120126 BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
    K120147 ACE STAPLER AND CARTRIDGE
    K110829 ACE STAPLER AND CARTRIDGE
    K082044 ACE STAPLER, MODEL F0031