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510(k) Data Aggregation

    K Number
    K962972
    Device Name
    SURGICADE GAUZE SPONGE
    Manufacturer
    ACCUNEX CANADA,INC.
    Date Cleared
    1996-10-11

    (72 days)

    Product Code
    EFQ
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K922055,K942070
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Control bleeding, absorb body fluids, and protect wounds from contamination.

    Device Description

    Surgicade™ Non-Sterile Gauze Sponges are composed of USP Type VII gauze, ourgical on the each Spire Care Spirity and Compose of Carrype of Suble available in thicknesses of 8 ply (2" x 2", 4" x 4", 4" x 8"), 12 ply (2" x 2", 3" x 3", 4" x 4", 4"

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) summary for a medical device (Surgicade™ Non-Sterile Gauze Sponges) and focuses on administrative details, device description, intended use, and comparison to predicate devices for regulatory clearance. It does not include information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

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