KONIX ULTRASOUND GEL

KONIX ULTRASOUND GEL is an FDA 510(k)-cleared medical device (K101952) 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 May 26, 2011. Regulation: 8.