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510(k) Data Aggregation

    K Number
    K103718
    Device Name
    DYNACOR LUBRICATION GEL
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2011-05-10

    (140 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DYNACOR LUBRICATION GEL

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

    The gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "Lubrication Gel (Sterile)". This type of document is for a medical device approval and typically does not contain information about software algorithms, AI performance, or clinical study details as requested in your prompt.

    Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment can be found in this document.

    This letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It's a regulatory approval, not a technical performance report for an AI/software device.

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