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510(k) Data Aggregation

    K Number
    K250795

    Validate with FDA (Live)

    Device Name
    PUREVUE™ FMS
    Date Cleared
    2025-12-05

    (266 days)

    Product Code
    Regulation Number
    888.1100
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PUREVUE™ FMS is a dual arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

    Device Description

    The PUREVUE™ FMS is an arthroscopy pump with irrigation and suction function. The device is equipped with two independent peristaltic pump systems and can be used both as an irrigation pump and as a suction pump. This provides two options for operating the unit: the Single roller mode and the Dual roller mode.

    Single roller mode (Inflow): In this mode, the Inflow Cassette Tube transmits fluid from saline bags to the inflow cannula or sheath at the surgical site.

    Dual roller mode (Inflow/Outflow): This mode uses both the inflow and outflow functions of the pump via the Inflow Cassette Tube and Outflow Cassette Tube.

    The device is non-invasive and designed to be placed in non-sterile areas.

    The PUREVUE™ FMS is a fluid management system based on the peristaltic principle that provides irrigation and suction functionalities for arthroscopic procedures. Along with its accessories (Tube set for irrigation (single-use), Tube set for suction (2-lines, single-use), Day use tube set for irrigation (pump part, 10 applications), Patient tube for irrigation (single-use), Tube set for suction (1-line, single-use), Tube set inflow 4-spike adaptor, Tube set for vacuum incl. filter (30-day use, reusable), autoclavable remote control and double foot switch), the device delivers medical sterile irrigation fluid from fluid bags to the cavity. This distends the cavity to create space for the procedure. In addition, the device along with its accessories can aspirate fluid from the patient's cavity to improve the visibility.

    AI/ML Overview

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