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510(k) Data Aggregation

    K Number
    K102452
    Device Name
    DEFOGGING AND CLEANING SOLUTION- FLO-X
    Manufacturer
    MINIMALLY INVASIVE DEVICES LLC
    Date Cleared
    2010-12-23

    (118 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINIMALLY INVASIVE DEVICES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the laparoscope lens thereby maintaining visualization of the surgical site.
    Device Description
    The Minimally Invasive Defogging and Cleaning Solution is a biocompatible surfactant (Docusate Sodium) when used as indicated. It functions in the same manner as the predicate devices. It is intended to be used to prevent fogging of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries. Additionally, the solution can be used to clean the end of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries (i.e. to rinse lens intra-operatively by rinsing any debris from the lens which becomes attached to the lens as a result of the procedure.)
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    K Number
    K080613
    Device Name
    CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
    Manufacturer
    MINIMALLY INVASIVE DEVICES LLC
    Date Cleared
    2008-11-06

    (247 days)

    Product Code
    OCT, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINIMALLY INVASIVE DEVICES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clear-Vu System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site.
    Device Description
    The Clear-Vu System consists of a multi-lumen sheath assembly mounted on the shaft of the laparoscope, which connects to the existing CO₂ insufflation circuit to defog the laparoscope lens and divert surgical debris, and connects to the existing surgical irrigation system to clean the lens via saline flush.
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