LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061829
    Device Name
    ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
    Manufacturer
    NEW LEAF MEDICAL, INC.
    Date Cleared
    2006-11-17

    (142 days)

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

    The BoVac Electrosurgery Suction Device removes smoke, odors, gases, particles, and fluids directly from the surgical site during electrosurgery procedures. The device is single-use and disposable.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the "BoVac Electrosurgery Suction Device." It indicates that the device has been found substantially equivalent to a predicate device, but it does not contain acceptance criteria or a study proving device performance against such criteria.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a dedicated study. This type of document typically does not include the detailed study information requested in the prompt.

    Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1