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510(k) Data Aggregation

    K Number
    K972112
    Device Name
    INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450
    Manufacturer
    TAUT, INC.
    Date Cleared
    1997-12-01

    (179 days)

    Product Code
    GBW
    Regulation Number
    878.4200
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450

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

    THE DEVICE IS INTENDED FOR USE AS AN ABDOMINAL ACCESS PORT DURING LAPARASCOPIC PROCEDURE AND THE VALVE FOR ATTACHING INSUFFLATION TUBING TO MAINTAIN PNEUMOPERITONEAL PRESSURE.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance testing, or any studies conducted on the device "Introducer Port SC" (K972112). The document is solely an FDA 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It does not contain details regarding performance studies, clinical trials, or any specific acceptance criteria that the device had to meet.

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