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

    CELERITY 20 HP Biological Indicator

    K Number: K172752 · Decision Feb 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    202
    Applicant Total
    24
    Review Days
    150

    Basic Information

    Device Name
    CELERITY 20 HP Biological Indicator
    K Number
    K172752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Steris Corporation
    Date Received
    September 12, 2017
    Decision Date
    February 9, 2018
    Product Code
    FRC
    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
    FRC Indicator, Biological Sterilization Process

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