Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K202593
    Device Name
    Turbett Instrument Pod
    Manufacturer
    Turbett Surgical Inc.
    Date Cleared
    2021-05-19

    (253 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Turbett Surgical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Turbett Instrument Pod is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turbett Surgical filters. The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132C) and exposure time of 4 minutes. . The TS1500 Container may be loaded to a maximum weight of 375 lbs. in any tray. Minimum drying time for loads up to 140 lbs. is 10 minutes, for loads up to 375 lbs. 30 minutes. . The TS1200 Container may be loaded to a maximum weight of 120 lbs. in any tray. Minimum drving time is 10 minutes. The TS1000 Container may be loaded to a maximum weight of 100 lbs. not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes. The system was validated with 1mm x 500mm lumens. . Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.
    Device Description
    The Turbett Instrument Pod is a rigid sterilization container with a fenestrated door holding a single-use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Trays within the container are separated by dividers to ensure separation and maximum steam exposure. The container is available in three sizes (TS1500 34"x24"x22"; TS1200 34" x17" x22"; TS1000 23" x17" x 22"). The original container (TS1500) has been validated to sterilize 375 lbs. of instruments along with the dividers. The validation was conducted with 15 instrument trays at 25 lbs. each to represent the most challenging case. Additional containers include the TS1200 and TS1000 sizes which can hold 120 lbs. of instruments. Sterilized instruments can be transported and stored for up to 30 days within the closed container. The Turbett Instrument Pod is loaded into the autoclave with a dedicated transfer carriage. The container is constructed of 304 stainless steel with an anodized aluminum filter housing/door. The use of a single-use disposable filter cartridge installed in the fenestrated door eliminates the need for a sealed gasket found on other rigid containers. The omission of a reusable gasket eliminates contamination risks due to failed reusable gaskets.
    Ask a Question
    K Number
    K200240
    Device Name
    Turbett Instrument Pod
    Manufacturer
    Turbett Surgical Inc.
    Date Cleared
    2020-04-30

    (90 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Turbett Surgical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Turbett Instrument Pod is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turbett Surgical filters. The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132℃) and exposure time of 4 minutes. o The TS1500 Container may be loaded to a maximum weight of 375 lbs. not to exceed 25 lbs. in any tray. Minimum drying time for loads up to 140 lbs. is 10 minutes, for loads up to 375 lbs. 30 minutes. . The TS1200 Container may be loaded to a maximum weight of 120 lbs. not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes. The TS1000 Container may be loaded to a maximum weight of 100 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes. The system was validated with 1mm x 500mm lumens. Do not use with instruments containing lumens with an inner diameter of smaller than 1mm and an overall length longer that 500mm. Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.
    Device Description
    The Turbett Instrument Pod is a rigid sterilization container with a fenestrated door holding a single-use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Trays within the container are separated by dividers to ensure separation and maximum steam exposure. The container is available in three sizes (TS1500 34"x24"x22"; TS1200 34" x17" x22"; TS1000 23" x17" x 22"). The original container (TS1500) has been validated to sterilize 375 lbs. of instruments along with the dividers. The validation was conducted with 15 instrument trays at 25 lbs. each to represent the most challenging case. Additional containers include the TS1200 and TS1000 sizes which can hold 120 lbs. of instruments. Sterilized instruments can be stored for up to 30 days within the closed container. The Turbett Instrument Pod is loaded into the autoclave with a dedicated transfer carriage. The container is constructed of 304 stainless steel with an anodized aluminum filter housing/door. The use of a single-use disposable filter cartridge installed in the fenestrated door eliminates the need for a sealed gasket found on other rigid containers. The omission of a reusable gasket eliminates contamination risks due to failed reusable gaskets.
    Ask a Question

    Page 1 of 1