RELiZORB (100300/100301)

RELiZORB (100300/100301) is an FDA 510(k)-cleared medical device (K250499) manufactured by Alcresta Therapeutics, Inc.. 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 April 16, 2025. Regulation: 8.