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

    SANICLAVE 200

    K Number: K112811 · Decision Jan 11, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    2
    Review Days
    106

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SANICLAVE 200
    K Number
    K112811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alternative Pioneering Research and Development
    Date Received
    September 27, 2011
    Decision Date
    January 11, 2012
    Product Code
    FLE
    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
    FLE Sterilizer, Steam

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FLE), ordered by most recent decision date.

    Enbio PRO

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Getinge GSS67N Series Steam Sterilizer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Cassette Autoclave (ACA5)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Steam Sterilizer (2545D)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FRONT-LINE Field Sterilizer (FL135)

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Alternative Pioneering Research and Development

    K Number Device Name
    K122978 SANICLAVE 102, MODEL RS-SC-102