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510(k) Data Aggregation

    K Number
    K983016
    Device Name
    GAUZE, SPONGES, CAT # 11-003
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    1999-02-12

    (168 days)

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

    GAUZE, SPONGES, CAT # 11-003

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

    Wound cover for patient care.

    Device Description

    Gauze, Sponges Various Sizes, Non-Sterile and Sterile

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Gauze Sponges." This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies typically associated with AI/ML device evaluations.

    Therefore, I cannot fulfill your request for the specific information regarding a study, as this information is not present in the provided text. The document is simply an FDA clearance for a medical device (gauze sponges) that was deemed substantially equivalent to existing devices, without the need for the types of performance studies you are asking about for AI/ML products.

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