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510(k) Data Aggregation

    K Number
    K990584
    Device Name
    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
    Manufacturer
    BROADLINE MEDICAL INDUSTRIES
    Date Cleared
    1999-04-23

    (59 days)

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

    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

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

    The intended uses of gauze sponges are absorption of blood and body fluids, wound dressing, prepping and scrubbing, and debridement. This product is patient contacting material.

    Device Description

    GAUZE SPONGES

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding Broadline Gauze Sponges. This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document is a regulatory approval notice, not a scientific study report.

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