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510(k) K190864

Konix Anti-Fog Solution by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler — Product Code OCT

K190864 is an FDA 510(k) premarket notification submitted by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler for the device "Konix Anti-Fog Solution". The FDA issued a decision of Substantially Equivalent on August 27, 2020. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2020
Date Received
April 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti Fog Solution And Accessories, Endoscopy
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

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FDA data resources