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510(k) Data Aggregation

    K Number
    K061316
    Device Name
    MEDLINE SURGICAL SPONGE SCANNER
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2006-11-02

    (175 days)

    Product Code
    LWH
    Regulation Number
    880.2740
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDLINE SURGICAL SPONGE SCANNER

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

    The Medline Surgical Sponge Scanning System is intended to be used to augment current sponge counting practice by providing a means to electronically detect potentially retained springes,

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Medline Surgical Sponge Scanning System. It does not contain information about acceptance criteria, study design, or device performance metrics.

    Therefore, I cannot answer your request based on the provided input. The document mainly states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

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