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

    EsophyX® Z Device with SerosaFuse Fasteners and Accessories

    K Number: K160960 · Decision May 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    11
    Review Days
    26

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    Basic Information

    Device Name
    EsophyX® Z Device with SerosaFuse Fasteners and Accessories
    K Number
    K160960
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endogastric Solutions, Inc.
    Date Received
    April 5, 2016
    Decision Date
    May 1, 2016
    Product Code
    ODE
    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
    ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

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    Other Clearances by Endogastric Solutions, Inc.

    K Number Device Name
    K240879 EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
    K172811 EsophyX Z, EsophyX2 HD
    K171307 EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
    K143645 EsophyX® Z Fastener Delivery Device
    K142113 ESOPHYX2 HD
    K092400 ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
    K091832 ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
    K073644 ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
    K071651 EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES
    K062875 ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
    Search all 11 clearances from Endogastric Solutions, Inc. →