Advance Medical Designs, Inc. Sterile Ultrasound Gel

Advance Medical Designs, Inc. Sterile Ultrasound Gel is an FDA 510(k)-cleared medical device (K163050) manufactured by Advance Medical Designs, 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 24, 2017. Regulation: 8.