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510(k) Data Aggregation

    K Number
    K990428
    Device Name
    DRAINAGE BAG
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    1999-08-12

    (182 days)

    Product Code
    EXF
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection.

    Device Description

    Drainage Bag

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a Drainage Bag (K990428). This type of document is a regulatory approval and does not contain information about device acceptance criteria, performance studies, or AI performance metrics as requested in the prompt.

    Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on:

    1. Confirming that the device is substantially equivalent to legally marketed predicate devices.
    2. Outlining the regulatory requirements for marketing the device.
    3. Stating the intended use of the device.

    There is no data presented in this document about clinical studies, test sets, ground truth, or AI performance.

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