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510(k) Data Aggregation

    K Number
    K152948
    Device Name
    Medline Anti-Fog Solution
    Manufacturer
    Medline Industries, Inc.
    Date Cleared
    2016-02-04

    (121 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Medline Anti-Fog Solution

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

    The anti-fog solution is intended to be used to prevent 'fogging'' (caused by condensation) on the lenses of endoscopic/ laparoscopic instruments which are likely to fog during use.

    Device Description

    Not Found

    AI/ML Overview

    This appears to be a 510(k) clearance letter from the FDA for a medical device (Medline Anti-Fog Solution). This document does not contain information about acceptance criteria, study details, or performance metrics for a device that typically involves AI or software, as the product is a chemical solution.

    The document primarily focuses on:

    • Confirming substantial equivalence to a predicate device.
    • Outlining regulatory compliance requirements for the manufacturer.
    • Stating the intended use of the anti-fog solution.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert involvement, or AI performance. The provided text does not contain any of these elements.

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