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510(k) Data Aggregation

    K Number
    K023261
    Device Name
    ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
    Manufacturer
    TAUT, INC.
    Date Cleared
    2002-12-13

    (74 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244

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

    The ADAPI™ Balloon Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device called the "ADAPT™ Balloon Open Access Port Model 41244," dated December 13, 2002. It outlines the regulatory approval for this device, stating that it is substantially equivalent to legally marketed predicate devices.

    This document describes the device, its indication for use, and regulatory information, but it does not contain any information about acceptance criteria for device performance, a study proving it meets such criteria, or details regarding AI or algorithm performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as that information is not present in the provided text.

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