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510(k) Data Aggregation

    K Number
    K963184
    Device Name
    OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1996-12-31

    (139 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K950076,K950103,K955120
    Why did this record match?
    Device Name :

    OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM

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

    The Olympus Endoscopic Vessel Harvesting System is specifically designed for subcutaneous endoscopy - - more specifically for endoscopically gaining access to, ligating and/or harvesting vessels (e.g. veins, arteries, ducts, nerve) within the subcutaneous and subfacial surgical planes in the lower extremities.

    Device Description

    Olympus Endoscopic System for Vessel Harvesting: endoscope, associated accessories and ancillary equipment.

    AI/ML Overview

    The provided document is a 510(k) summary for the Olympus Endoscopic System for Vessel Harvesting, which describes the device's technical characteristics, intended use, and comparison to predicate devices. It does not contain any information regarding clinical studies, acceptance criteria, or performance data as typically found in an AI/imaging device submission.

    Therefore, I cannot provide the requested information in the table or the subsequent points because the document does not include it. The summary focuses on demonstrating substantial equivalence to predicate devices based on design, function, and intended use, rather than presenting de novo performance data against pre-defined acceptance criteria.

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