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510(k) Data Aggregation

    K Number
    K190864
    Device Name
    Konix Anti-Fog Solution
    Manufacturer
    Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
    Date Cleared
    2020-08-27

    (512 days)

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

    Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KONIX Anti-Fog solution is a sterile, disposable, functional, anti-fog solution. The antifog solution is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. KONIX Antifog Solution is used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.
    Device Description
    Konix Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is released to the market as sterile and disposable with one polyurethane foam pad in a 6 ml polyethylene bottle. Secondary packaging is composed of PET film and Medical Kraft Sealing Paper. Konix Anti-Fog Solution is intended to be used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures. The mechanism of defogging or anti-fogging action of Konix Anti-Fog Solution, works by physically changing the water droplets that form on the lens surface from round droplets, to a flat transparent sheet of water, a phenomenon known as 'wetting'.
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