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510(k) Data Aggregation

    K Number
    K201945
    Device Name
    KARL STORZ UDEL Sterilization Trays
    Date Cleared
    2021-02-25

    (227 days)

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

    Karl Storz EndoscopyAmerica Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KARL STORZ UDEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD and steam sterilization systems as indicated table. The system may be used with flexible endoscopes with lumen diameters ≥ 1.2mm and a maximum length of 845mm. KARL STORZ UDEL Sterilization Trays must be used in conjunction with an FDA cleared sterilization wrap or container.
    Device Description
    The KARL STORZ UDEL Sterilization Trays are intended only for use to encase specific KARL STORZ reusable medical devices for sterilization in steam and specified STERRAD Sterilization System cycles. The sterilization trays are not intended to maintain sterility by themselves. Prior to sterilization, the trays must be double-wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray. The tray configurations, available in various sizes, are designed to encase specific KARL STORZ medical devices, such as fiber optic light cable, flexible endoscopes, and camera heads. Some of the trays are specifically molded to fit and accommodate KARL STORZ light cables, flexible endoscopes, camera heads and rigid telescopes, allowing the instruments to be arranged in an organized manner when placed in the tray. All systems consist of a Udel plastic base and Udel plastic lid. Lids are attached to the trays with assembled hardware. Baskets are injection molded and trays are thermoformed from Udel polysulfone polymer (sourced from Solvay Specialty Polymers), which is compatible with all indicated sterilization modes. The sterilization trays are constructed with a perforated lid and base to allow for permeation of sterilant during sterilization. Some of the tray configurations are simply molded into the form of a mesh. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone holders and mats (depending on the tray type) to secure instruments and provide protection of the medical devices in the sterilization tray. The holders and mats are manufactured from silicone material, which is also compatible with all sterilization modes.
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