NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is an FDA 510(k)-cleared medical device (K233229) manufactured by Anx Robotica Corporation. 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 4, 2024. Regulation: 8.