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

    STERISAFE HP TABLE-TOP STEAM STERILIZER

    K Number: K140736 · Decision Jan 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    1
    Review Days
    302

    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
    STERISAFE HP TABLE-TOP STEAM STERILIZER
    K Number
    K140736
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Milton E Pedrazzi D.D.S., Inc.
    Date Received
    March 24, 2014
    Decision Date
    January 20, 2015
    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