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

    STERRAD 50 & STERRAD 100S STERILIZERS

    K Number: K023290 · Decision Apr 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    25
    Applicant Total
    54
    Review Days
    183

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    Basic Information

    Device Name
    STERRAD 50 & STERRAD 100S STERILIZERS
    K Number
    K023290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Sterilization Products
    Date Received
    October 2, 2002
    Decision Date
    April 3, 2003
    Product Code
    FLF
    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
    FLF Sterilizer, Ethylene-Oxide Gas

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    Other Clearances by Advanced Sterilization Products

    K Number Device Name
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    K163598 Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
    K162007 STERRAD NX Sterilizer
    K160818 STERRAD® NX Sterilizer with ALLClear™ Technology
    K160903 STERRAD 100NX Sterilizer with ALLClearTM Technology
    K151725 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
    K151971 STERRAD CYCLESURE 24 Biological Indicator
    K142454 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
    K140977 EVOTECH ECR
    K141693 Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
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