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510(k) Data Aggregation

    K Number
    K972719
    Device Name
    CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
    Manufacturer
    MEDICEL, S.A. DE C.V.
    Date Cleared
    1999-02-04

    (563 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Claricel sterilization pouches and reels are indicated to enclose another medical device that is to be steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 or ST-41 sterilization recommendations.

    Device Description

    Claricel Sterilization Pouches and Reels

    AI/ML Overview

    This is a 510(k) premarket notification for "Claricel sterilization pouches and reels". The provided text is a letter from the FDA determining substantial equivalence, along with the Indications For Use statement. It does not contain specific details about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance data from a specific study designed to meet acceptance criteria.

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