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510(k) Data Aggregation

    K Number
    K970888
    Device Name
    IOTEC TROCAR AND FLEXIBLE CANNULA
    Manufacturer
    IOTEC INDUSTRIES
    Date Cleared
    1998-01-09

    (304 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K940587,K931111
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The product is intended to create a point of entry for curved endoscopic instruments into the abdominal and chest cavities during a endoscopic procedure.

    Device Description

    The Iotec Trocar and Flexible Cannula is composed of Plastic, Stainless Steel (or plastic rod) for attachment of the trocar tip; and a flexible plastic cannula tube.

    AI/ML Overview

    The provided text is a 510(k) summary for the Iotec Trocar and Flexible Cannula, which is a medical device used to create an entry point for endoscopic instruments. The document focuses on establishing substantial equivalence to predicate devices rather than providing performance data from clinical trials or usability studies.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text. This type of submission relies on demonstrating similarity to already approved devices (predicate devices) rather than presenting new performance data against specific acceptance criteria.

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