Radiance Ultra Series ZeroWire Embedded

Radiance Ultra Series ZeroWire Embedded is an FDA 510(k)-cleared medical device (K161228) manufactured by Nds Surgical Imaging, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 2016. Regulation: 8.