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510(k) Data Aggregation

    K Number
    K083358
    Device Name
    LUBRICANO-ULTRASOUND
    Manufacturer
    FARCO PHARMA GMBH
    Date Cleared
    2009-01-09

    (87 days)

    Product Code
    MUI
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    FARCO PHARMA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lubricano is an in vivo biocompatible and bioexcretable sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications. Lubricano is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures, such as transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, intracavity ultrasound imaging, and gel infusion sonography. Lubricano is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are required.
    Device Description
    Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
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    K Number
    K081990
    Device Name
    LUBRICANO STERILE GEL
    Manufacturer
    FARCO PHARMA GMBH
    Date Cleared
    2008-12-05

    (144 days)

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

    FARCO PHARMA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile gel for human use, e.g. in medical procedures - to aid the introduction of catheters and endoscopic instruments in transurethral examinations, and in intermittent catheterization - particularly for incontinence treatment.
    Device Description
    Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano® Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano® Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
    Ask a Question

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