MiVu™ Esophageal Endo Cap

MiVu™ Esophageal Endo Cap is an FDA 510(k)-cleared medical device (K230056) manufactured by Diversatek Healthcare. 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 24, 2023. Regulation: 8.