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510(k) Data Aggregation

    K Number
    K023767
    Device Name
    UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Date Cleared
    2002-11-29

    (17 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K970184
    Why did this record match?
    Device Name :

    UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES

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

    This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.

    Device Description

    This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.

    AI/ML Overview

    This document describes the UES-30 Electrosurgical Unit, a Class II medical device, for which a 510(k) premarket notification was submitted. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission for premarket clearance and focuses on substantial equivalence to a predicate device.

    Therefore, the requested information (points 1-9) cannot be extracted from the provided text as it is not present.

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