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510(k) Data Aggregation

    K Number
    K992904
    Device Name
    MINI-PORT
    Manufacturer
    TAUT, INC.
    Date Cleared
    1999-10-05

    (36 days)

    Product Code
    GBW,HIF
    Regulation Number
    878.4200
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K070352
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use as an abdominal access port during a laparoscopic procedure and the 1-way stopcock for attaching insufflation tubing to maintain pneumoperitoneal pressure.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter for a Peritoneal Catheter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

    The letter is a regulatory approval document and not a scientific or clinical study report. Therefore, I cannot extract the requested information as it is not present in the provided text.

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