LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983298
    Device Name
    BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
    Manufacturer
    BUFFALO FILTER CO., INC.
    Date Cleared
    1999-08-16

    (329 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER -

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

    The Indications for Use of the ViroSafe EY Filter and Buffalo Filter® EY Prefilter are for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, or other smoke plume producing devices. This device is not intended for contact with the patient, It is intended to be used during either open or endoscopic surgical procedures.

    Device Description

    Disposable Smoke Evacuation Filter

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a smoke evacuation filter. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These types of details are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.

    Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1