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

    OverStitch Endoscopic Suturing System and Accessories

    K Number: K181141 · Decision Jun 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    69
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    OverStitch Endoscopic Suturing System and Accessories
    K Number
    K181141
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apollo Endosurgery
    Date Received
    May 1, 2018
    Decision Date
    June 27, 2018
    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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