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

    CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)

    K Number: K970907 · Decision Nov 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    9
    Review Days
    246

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    Basic Information

    Device Name
    CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)
    K Number
    K970907
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Getinge/Castle, Inc.
    Date Received
    March 11, 1997
    Decision Date
    November 12, 1997
    Product Code
    FLE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLE Sterilizer, Steam

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    Other Clearances by Getinge/Castle, Inc.

    K Number Device Name
    K020205 CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT
    K020590 MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
    K012573 CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC
    K003441 CASTLE MODEL 233HC STEAM STERILIZER
    K994314 CASTLE SERIES 100HC STEAM STERILIZERS
    K993242 CASTLE SURGICAL LIGHT, MODEL 3000
    K974084 GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
    K973225 CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)