BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Tristel OPH

    K Number: K242732 · Decision May 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    241

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    Basic Information

    Device Name
    Tristel OPH
    K Number
    K242732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6886
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tristel Solutions , Ltd.
    Date Received
    September 10, 2024
    Decision Date
    May 9, 2025
    Product Code
    QWS
    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
    QWS Foam Or Gel Chemical Sterilant/High Level Disinfectant

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