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

    UroLift System Rigid Retrieval Kit Sterilization Tray

    K Number: K212396 · Decision Oct 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    17
    Review Days
    81

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    Basic Information

    Device Name
    UroLift System Rigid Retrieval Kit Sterilization Tray
    K Number
    K212396
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neotract, Inc.
    Date Received
    August 2, 2021
    Decision Date
    October 22, 2021
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Neotract, Inc.

    K Number Device Name
    K232558 UroLift 2 ATC Advanced Tissue Control System
    K201837 UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
    K200441 UroLift Advanced Tissue Control (ATC) System
    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. →