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

    DiLumen C1, EZ1 and Tool Mount

    K Number: K221452 · Decision Feb 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    8
    Review Days
    268

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    Basic Information

    Device Name
    DiLumen C1, EZ1 and Tool Mount
    K Number
    K221452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lumendi, LLC
    Date Received
    May 18, 2022
    Decision Date
    February 10, 2023
    Product Code
    FDF
    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
    FDF Colonoscope And Accessories, Flexible/Rigid

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    Other Clearances by Lumendi, LLC

    K Number Device Name
    K211819 DiLumen C2 and Tool Mount
    K210851 DiLumen Endolumenal Interventional Platform (DiLumen)
    K183112 DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)
    K182540 DiLumen Endolumenal Interventional Platform
    K173405 DiLumen Endolumenal Interventional Scissors (DiLumen Is)
    K173317 DiLumen C2; DiLumen Tool Mount
    K162428 DiLumen Endolumenal Interventional Platform