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510(k) Data Aggregation

    K Number
    K972298
    Device Name
    ETB TELESCOPE W/WORKING CHANNEL FOR SEPS
    Manufacturer
    THE ALTOMEC CORP.
    Date Cleared
    1998-01-30

    (225 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K972298
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SEPS Videoscope is a telescope with working channel and outer sheath for the endoscopic sufascial dissection of the venea perforantes and fasciotomy. The instrument is introduced into a natural or artificial body cavities to illuminate them and to transmit an optical image from inside the cavity. The working channel allows to introduce instruments into the cavity.

    Device Description

    The SEPS Videoscope is a telescope with working channel and outer sheath.

    AI/ML Overview

    The provided document is a 510(k) summary for the "ETB Telescope w/ Working Channel for SEPS" and primarily focuses on the FDA's "substantially equivalent" determination to a predicate device. It does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or the detailed aspects of a clinical study as requested.

    Therefore, I cannot provide the requested information from this document. The document primarily serves as an FDA clearance letter based on a regulatory review, not a detailed scientific study report.

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