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510(k) Data Aggregation

    K Number
    K971178
    Device Name
    RAND SURGICAL SPONGE
    Manufacturer
    TRANS AIRE
    Date Cleared
    1997-06-27

    (88 days)

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

    Intended to be placed directly on wound or burn in absort excess body fiuids or exudale

    Device Description

    Rand Surgical Sponge

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Rand Scientific Corporation for a device named "Rand Surgical Sponge." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

    However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or details about training sets.

    Therefore, I cannot fulfill your request for the specific information you asked for based on the provided document. The document is a regulatory approval letter, not a scientific study report.

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