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510(k) Data Aggregation

    K Number
    K974638
    Device Name
    STERITITE SEALED CONTAINERS MODEL SCO4Q
    Manufacturer
    CASE MEDICAL, INC.
    Date Cleared
    1997-12-18

    (69 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STERITITE SEALED CONTAINERS MODEL SCO4Q

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SteriTite "11 product line is a Reusable Rigid Sterilization Container system intended to be used for the sterilization of surgical instruments for a hospital or other health care institution.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the Steritite™ Rigid Sterilization Containers does not include the detailed information regarding acceptance criteria, study design, and performance metrics that you are requesting.

    The letter primarily confirms that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and outlines the general regulatory requirements for marketing the device. It does not contain a summary of the performance testing or the specific acceptance criteria and study results.

    To answer your questions, I would need access to the actual 510(k) submission document or a summary of its contents, which typically contains the technical details of the device's testing and performance.

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