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

    STERILUCENT STERILIZATION CONTAINER SYSTEM

    K Number: K142109 · Decision Jan 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    7
    Review Days
    169

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    Basic Information

    Device Name
    STERILUCENT STERILIZATION CONTAINER SYSTEM
    K Number
    K142109
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterilucent, Inc.
    Date Received
    August 4, 2014
    Decision Date
    January 20, 2015
    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 Sterilucent, Inc.

    K Number Device Name
    K192001 Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
    K191999 Sterilucent VH2O2 Chemical Indicators
    K190005 Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
    K141238 STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR
    K140464 STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
    K141312 STERILUCENT PROCESS CHALLENGE DEVICE