510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190864Substantially Equivalent

Konix Anti-Fog Solution

Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler, Istanbul, TR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190864 is the FDA 510(k) clearance record for Konix Anti-Fog Solution, a class II device, cleared for Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler on under FDA product code OCT (Anti Fog Solution And Accessories, Endoscopy). FDA's definition for product code OCT reads: "To prevent, reduce or eliminate condensation (fog) on endoscopic lens". FDA records list one 510(k) clearance for Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler. As of , FDA records show no recalls naming K190864.

Clearance record

Decision date
Received
(512 days to decision)
Product code
OCT Anti Fog Solution And Accessories, Endoscopy
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler San. Ve Tic. Ltd, Istanbul, TR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCT

Trailing 12 months

FDA records hold no clearances under product code OCT in the trailing twelve months.

FDA records show no clearances under product code OCT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260