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510(k) Data Aggregation

    K Number
    K250011
    Device Name
    Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)
    Manufacturer
    Turbett Surgical
    Date Cleared
    2025-04-04

    (92 days)

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

    Turbett Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Turbett Surgical 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 Turbett Surgical Filters. The unit is intended to be used in a pre-vacuum steam sterilizers with a pre-vacuum cycle of 270°F (132°C) and exposure time of 4 minutes. - 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 140lbs. is 10 minutes, for loads up to 375 lbs. is 30 minutes. - The TS1200 Container may be loaded to a maximum weight of 300 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes for loads up to120 lbs. and 30 minutes for loads up to 300 lbs. - 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 0.7 mm x 500 mm and 1.0 mm x 850 mm rigid and flexible lumens. Use only uncovered, perforated, or wire mesh general delivery trays within the Turbett Surgical Instrument Pod.
    Device Description
    The Turbett Surgical Instrument Pod is a multi-tray 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. Unwrapped, uncovered, perforated sterilization trays are stacked into the container, separated by anodized aluminum dividers, which allow steam to evenly penetrate and allow condensation to drain. The container is manufactured from 304 stainless steel sheet metal and bar stock. The container is sealed on all sides except one which is the door / filter panel. The single fenestrated door consists of two perforated anodized aluminum panels which cover the exposed container side wall. A custom-made disposable filter consisting of 2 layers of filter paper separated by a layer of compressible single-use gasket material is placed between the two perforated metal panels of the door. Spring loaded latches compress the anodized aluminum door frame with filter assembly to the container for a secure seal. The Turbett Surgical Instrument Pod is loaded into the auto clave with a dedicated transfer mechanism and cart.
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    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.
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    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.
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    K Number
    K153025
    Device Name
    Turbett Surgical Container
    Manufacturer
    TURBETT SURGICAL LLC
    Date Cleared
    2016-01-14

    (90 days)

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

    TURBETT SURGICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Turbett Surgical Container 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 Turbett Surgical filters. The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F (132°C) and exposure time of 4 minutes. The container may be loaded with up to 15 trays and up to 25 lbs. per tray. Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens. The total weight of instruments and trays validated is 375 lbs. Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.
    Device Description
    The Turbett Surgical Container 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 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. Actual expected loads in hospital settings are likely to be less. Sterilized instruments can be stored for up to 30 days within the closed container. The Turbett Surgical Container 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.
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