BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    endomina system

    K Number: K211309 · Decision Dec 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    68
    Applicant Total
    1
    Review Days
    221

    Basic Information

    Device Name
    endomina system
    K Number
    K211309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endo Tools Therapeutics S.A.
    Date Received
    April 30, 2021
    Decision Date
    December 7, 2021
    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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