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510(k) Data Aggregation

    K Number
    K972074
    Device Name
    SUCTION INSTRUMENTATION
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Date Cleared
    1997-07-25

    (52 days)

    Product Code
    GCX,80G
    Regulation Number
    880.6740
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SUCTION INSTRUMENTATION

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

    The suction devices, when attached to an external source of vacuum, are used for aspiration, removal, or sampling of body fluids during surgical procedures.

    Device Description

    These devices are rigid, hollow tips or tubes, that when attached to an external source of vacuum are used for aspiration, removal, or sampling of body fluids during surgical procedures. Some suction devices are fitted with Fiber Optic bundles.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Walter Lorenz Surgical, Incorporated, regarding "Suction Instrumentation." It is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices.

    This document does not contain any information regarding specific acceptance criteria, performance metrics, or details of a study (clinical or otherwise) that would prove the device meets such criteria.

    Therefore, I cannot fulfill your request for the tables and information outlined because the source material does not provide it. The document confirms the device's regulatory classification, intended use, and substantial equivalence to existing devices but does not delve into empirical performance data or study methodologies.

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