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

    troCarWash™ System

    K Number: K233442 · Decision May 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    92
    Applicant Total
    10
    Review Days
    216

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    Basic Information

    Device Name
    troCarWash™ System
    K Number
    K233442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotex, Inc.
    Date Received
    October 18, 2023
    Decision Date
    May 21, 2024
    Product Code
    OCX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCX Endoscopic Irrigation/Suction System

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