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

    ACE STAPLER AND CARTRIDGE

    K Number: K110829 · Decision Jun 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    69
    Applicant Total
    5
    Review Days
    71

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    Basic Information

    Device Name
    ACE STAPLER AND CARTRIDGE
    K Number
    K110829
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Barosense, Inc.
    Date Received
    March 24, 2011
    Decision Date
    June 3, 2011
    Product Code
    OCW
    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
    OCW Endoscopic Tissue Approximation Device

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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
    K082044 ACE STAPLER, MODEL F0031
    K082589 BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034