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

    UroLift Advanced Tissue Control (ATC) System

    K Number: K200441 · Decision Jun 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    10
    Applicant Total
    17
    Review Days
    102

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    Basic Information

    Device Name
    UroLift Advanced Tissue Control (ATC) System
    K Number
    K200441
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5530
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neotract, Inc.
    Date Received
    February 24, 2020
    Decision Date
    June 5, 2020
    Product Code
    PEW
    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
    PEW Implantable Transprostatic Tissue Retractor System

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    Other Clearances by Neotract, Inc.

    K Number Device Name
    K232558 UroLift 2 ATC Advanced Tissue Control System
    K212396 UroLift System Rigid Retrieval Kit Sterilization Tray
    K201837 UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
    K192781 UroLift System Procedure Kit Sterilization Tray
    K193269 UroLift System (UL400)
    K190377 UroLift System UL400
    K173087 UroLift System (UL400 and UL500)
    K172359 UroLift System (UL500)
    K162345 UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
    K153584 NeoTract UroLift System UL500
    Search all 17 clearances from Neotract, Inc. →