Clearance Summary
Konix Anti-Fog Solution received FDA 510(k) clearance under submission number K190864, sponsored by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-08-27.
- Submission: K190864
- Applicant / Sponsor: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2020-08-27
Classification & Regulation
This clearance is catalogued under FDA product code OCT and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.