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510(k) Data Aggregation

    K Number
    K231489
    Device Name
    Sturdy Autoclave Super Microm
    Manufacturer
    Sturdy Industrial Co., Ltd
    Date Cleared
    2023-06-21

    (29 days)

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

    Sturdy Industrial Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA and SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact.
    Device Description
    The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is a table-top steam sterilizers that uses saturated steam at high pressures and temperatures and kills infectious bio-organisms. The steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to the established time, temperature, and pressure parameters. Items to be sterilized are placed in the sterilization chamber. The user selects a sterilization cycle, and presses the start switch to initiate the cycle. The sterilizer will automatically fill water into the chamber, heat the water into steam, introduce steam-flush and pressure-pulses, hold at a set pressure, temperature, and time to sterilize the items, and automatically vent the steam and cool the chamber down after the sterilization is complete.
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    K Number
    K181993
    Device Name
    STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
    Manufacturer
    Sturdy Industrial Co., Ltd
    Date Cleared
    2019-11-01

    (463 days)

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

    Sturdy Industrial Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact.
    Device Description
    The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) uses saturated steam at high pressures and temperatures and kills infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature and pressure parameters. Devices to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle and presses the appropriate switch. The sterilizer automatically fills the chamber, heats the water into steam, four times pulse sterilizes the items, and automatically vents the steam and cools the chamber after sterilization is complete.
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    K Number
    K032596
    Device Name
    STURDY MANUAL RESUSCITATOR
    Manufacturer
    STURDY INDUSTRIAL CO., LTD
    Date Cleared
    2004-08-05

    (349 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    STURDY INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STURDY Manual Resuscitator is intended for manually-powered controlled or assisted ventilation with ambient air with or without additional oxygen. The child model is intended for patients weighing less than 30kg. The adult model is intended for patients weighing more than 30kg.
    Device Description
    Not Found
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