Search Results
Found 1 results
510(k) Data Aggregation
K Number
K190864Device 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
876.1500Why 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'.
Ask a Question
Page 1 of 1