Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K233675
    Device Name
    FMS VUE™ Fluid Management and Tissue Debridement System
    Manufacturer
    DePuy Mitek, Inc.
    Date Cleared
    2024-02-26

    (102 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    DePuy Mitek, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FMS VUE™ Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.
    Device Description
    The FMS VUE Fluid Management and Tissue Debridement System is an arthroscopic pump system designed to provide optimal visibility of the surgical field by computer-controlled fluid regulation of intra-articular pressure, and flow during arthroscopic procedures. The system integrates a tissue debridement for controlled cutting, burring, shaving and abrading of bone and soft tissue. The FMS VUE Fluid Management and Tissue Debridement System consists of irrigation pump, which controls joint pressure, and the suction pump, which controls the flow of saline and waste from the joint. The FMS VUE Fluid Management and Tissue Debridement System includes an integrated shaver console, intended to provide controlled cutting, burring, shaving and abrading of bone and soft tissue. The FMS VUE Fluid Management and Tissue Debridement System is designed to work with the existing FMS VUE platform accessories including: foot pedal, remote hand control, shaver handpieces, FMS connect cable, tubing sets, blades, and burrs. The FMS VUE Fluid Management and Tissue Debridement System contains updates in the hardware, which include replaced near obsolescence components and new real panel connectors. The FMS VUE Fluid Management and Tissue Debridement System software modification includes an additional shaver oscillation profile algorithm.
    Ask a Question

    Page 1 of 1