Safergel Sterile Ultrasound Gel

Safergel Sterile Ultrasound Gel is an FDA 510(k)-cleared medical device (K190591) manufactured by Safersonic Us, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 2019. Regulation: 8.