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510(k) Data Aggregation

    K Number
    K180272
    Device Name
    Saniclave 250
    Date Cleared
    2018-07-26

    (176 days)

    Product Code
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    REVOLUTIONARY SCIENCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Revolutionary Science Saniclave 250 is designed to be used in medical and dental clinics, hospitals and other facilities where reusable sterile equipment is used. It is intended to sterilize wrapped heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars (lumens greater than 3mm inner diameter and less than 70mm in length, excluding dental handpieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes.
    Device Description
    The Saniclave 250 by Revolutionary Science (model number RS-SC-250) is a 120 volt front loading autoclave. The Saniclave works like most other table top steam sterilizers by boiling water in a pressurized vessel (or chamber). As the water boils, the chamber pressurizes and the steam sterilizes the instruments placed inside. The Saniclave technology is based on the scientific concept that prolonged saturated pressurized steam at or over a temperature of 121degrees Celsius kills bacteria.
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