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510(k) Data Aggregation

    K Number
    K991694
    Device Name
    DYNAREX DRAIN SPONGE
    Manufacturer
    DYNAREX CORP.
    Date Cleared
    1999-07-15

    (58 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DYNAREX DRAIN SPONGE

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

    Non-woven dressing with pre-cut fenestration for use around tracheostomy or IV tubes to absorb exudate and absorb fluids.

    Device Description

    Sterile Drain Sponges

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device described as "Sterile Drain Sponges." This type of document does not contain any information regarding acceptance criteria, device performance studies, or AI/software analysis.

    The letter confirms that the device is substantially equivalent to a legally marketed predicate device, falling under the "Unclassified" regulatory class. It outlines general regulatory requirements but makes no mention of performance metrics or specific studies, as these types of devices (drain sponges) are typically cleared based on material composition and intended use rather than clinical performance studies.

    Therefore, I cannot provide the requested information based on the input document.

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