LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990894
    Device Name
    ETB TROCAR SYSTEM
    Manufacturer
    THE ALTOMEC CORP.
    Date Cleared
    1999-05-19

    (62 days)

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

    Telesopes (laparoscopy): Telescopes are used to illuminal cavity) by means of an external light source and to transmit an optical image from inside the cavity.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Trocar Systems and Rigid Endoscope Systems." This document approves the marketing of these devices based on their substantial equivalence to predicate devices. However, the letter itself does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information from the given input. The letter states that the FDA reviewed the 510(k) notification and determined substantial equivalence, implying that such studies and data were submitted, but the specific details are not present in this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1