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510(k) Data Aggregation

    K Number
    K203198
    Device Name
    KARL STORZ Metal Sterilization Trays
    Manufacturer
    Karl Storz Endoscopy America Inc
    Date Cleared
    2021-07-06

    (250 days)

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

    Karl Storz Endoscopy America Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ Metal Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycle (132ºC for four minutes with a 20 minute dry time). When used in conjunction with an FDA cleared sterility of the enclosed medical device is maintained until used. The system has been validated with devices with working channels >= 0.2mm and a maximum length of 240mm.
    Device Description
    The KARL STORZ-ENDOSCOPE Metal Sterilization Trays are intended only for use to encase various KARL STORZ reusable medical devices for sterilization in steam 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 are all baskets, available in various sizes, which are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a stainless steel metal mesh base and lid. Lids are attached to the trays with assembled hardware. The sterilization trays are constructed from mesh material to allow for permeation of sterilant during sterilization. The mesh basket design has a higher percentage of open cells than metal mesh allowing for complete permeation. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and provide protection of the medical devices in the sterilization tray.
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    K Number
    K203572
    Device Name
    Karl Storz Radel Sterilization Trays
    Manufacturer
    Karl Storz Endoscopy America Inc
    Date Cleared
    2021-05-07

    (151 days)

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

    Karl Storz Endoscopy America Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ RADEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycles (132°C 4 minutes). The KARL STORZ RADEL Sterilization Trays are intended to protect medical device instrumentation. When used in conjunction with an FDA cleared sterilization wrap. KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation chameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm.
    Device Description
    The KARL STORZ-ENDOSCOPE RADEL Sterilization Trays are intended only for use to encase various KARL STORZ reusable medical devices for sterilization in steam 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 KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a RADEL plastic base and lid. Lids are attached to the trays with assembled hardware. Some trays have a RADEL inner tray and/or silicone rubber mat. The sterilization trays are constructed with perforated/ventilated sides and lids to allow for permeation of sterilant during sterilization. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and silicone mats to provide protection of the medical devices in the sterilization tray.
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