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510(k) Data Aggregation

    K Number
    K992361
    Device Name
    PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
    Manufacturer
    PALL MEDICAL
    Date Cleared
    1999-08-20

    (36 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 :

    PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1

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

    The proposed device is intended for the filtration of contaminants from smoke, generated during laparoacopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria, and viruses).

    Device Description

    Pall Laparoscopic Smoke Filtration System

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study that proves a device meets such criteria. The letter acknowledges a device, states its regulatory class, and grants permission to market it, but it does not detail any performance studies.

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