KONIX STERILE GEL

KONIX STERILE GEL is an FDA 510(k)-cleared medical device (K130581) manufactured by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 17, 2014. Regulation: 8.