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510(k) Data Aggregation

    K Number
    K152933
    Device Name
    Vesalius
    Manufacturer
    TELEA ELECTRONIC ENGINEERING SRL
    Date Cleared
    2016-03-23

    (170 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vesalius Essential device and its accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopedic, arthroscopic, neurosurgery, ENT, and spinal procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided document does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Vesalius" electrosurgical device, detailing its regulation, classification, and indications for use. It does not include acceptance criteria, performance data, details of specific studies, sample sizes, or ground truth establishment methods for device performance.

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