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

    DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)

    K Number: K183112 · Decision Aug 2, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    8
    Review Days
    267

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    Basic Information

    Device Name
    DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)
    K Number
    K183112
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lumendi, LLC
    Date Received
    November 8, 2018
    Decision Date
    August 2, 2019
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Lumendi, LLC

    K Number Device Name
    K221452 DiLumen C1, EZ1 and Tool Mount
    K211819 DiLumen C2 and Tool Mount
    K210851 DiLumen Endolumenal Interventional Platform (DiLumen)
    K182540 DiLumen Endolumenal Interventional Platform
    K173405 DiLumen Endolumenal Interventional Scissors (DiLumen Is)
    K173317 DiLumen C2; DiLumen Tool Mount
    K162428 DiLumen Endolumenal Interventional Platform