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

    VERIFY Assert Self-Contained Biological Indicator

    K Number: K162701 · Decision Mar 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    204
    Review Days
    177

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    Basic Information

    Device Name
    VERIFY Assert Self-Contained Biological Indicator
    K Number
    K162701
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2805
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    STERIS Corporation
    Date Received
    September 28, 2016
    Decision Date
    March 24, 2017
    Product Code
    OWP
    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
    OWP Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

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