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510(k) Data Aggregation

    K Number
    K012168
    Device Name
    ADVANCE MEDICAL DESIGNS FLUID POUCH
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Date Cleared
    2001-09-18

    (68 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Advance Medical Designs Fluid Pouch is a body fluid drainage device. The Fluid Pouch is used for Hysteroscopy, Cystoscopy, Urology, and Brachytherapy procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a surgical fluid pouch, which focuses on regulatory approval based on substantial equivalence to a predicate device. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/ML device evaluation.

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