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510(k) Data Aggregation

    K Number
    K982306
    Device Name
    POLYTUBE
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    1998-09-22

    (83 days)

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

    POLYTUBE

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

    For the management, including cushioning of, and absorption of fluid around: Tracheostomy tube sites drainage tube sites Gastrointestinal tube sites feeding tube sites

    Device Description

    FERRIS POLYMEM POLYTUBE TUBE SITE DRESSING

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria. The text is a regulatory letter from the FDA regarding the 510(k) clearance of the Ferris Mfg. Corporation's Polytube device. It discusses the device's classification, marketing limitations, and general regulatory compliance. There is no mention of specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the given input.

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