510(k) K233229

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether by Anx Robotica Corporation — Product Code NEZ

K233229 is an FDA 510(k) premarket notification submitted by Anx Robotica Corporation for the device "NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether". The FDA issued a decision of Substantially Equivalent on January 5, 2024. The device falls under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. Anx Robotica Corporation has at least 2 other 510(k) clearances on record.