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510(k) Data Aggregation

    K Number
    K960400
    Device Name
    DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
    Manufacturer
    SNOWDEN-PENCER
    Date Cleared
    1996-03-12

    (43 days)

    Product Code
    FBM,GCJ,GEI
    Regulation Number
    876.5090
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K930666,K930667
    Predicate For
    K022989,K972927,K980016,K990144
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Various endoscopic surgical instruments for use in minimally invasive cardiac procedures including single bypass and multiple bypass (coronary artery bypass grafting (CABG)procedures), and saphenous vein harvesting.

    Device Description

    The devices are separated into several groups: endoscopes, endoscopic needle holders, endoscopic graspers and clamps, endoscopic scissors, endoscopic knife blade handles, hooks and clip appliers, endoscopic irrigation probes, endoscopic electrodes, retractors and rib spreaders, thoraports and cannulas.

    AI/ML Overview

    This document is a 510(k) summary for surgical instruments and does not contain information about acceptance criteria or a study proving device performance as might be found for a diagnostic or AI-driven device. It focuses on demonstrating substantial equivalence to previously cleared devices. Therefore, I cannot extract the requested information from this text.

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