ViSiGi 3D Gastric Sizing Tube

ViSiGi 3D Gastric Sizing Tube is an FDA 510(k)-cleared medical device (K234145) manufactured by Boehringer Laboratories. 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 January 25, 2024. Regulation: 8.