About This 510(k) Submission
K233229 is an FDA 510(k) clearance for the NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether, a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II — Special Controls, product code NEZ), submitted by Anx Robotica Corporation (Plano, US). The FDA issued a Cleared decision on January 5, 2024, 99 days after receiving the submission on September 28, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1300.