FDA 510(k) Applications for Medical Device Product Code "QKZ"

FDA 510(k) Number Applicant Device Name Decision Date
K221608 AnX Robotica Corp NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether 11/22/2022
K203192 AnX Robotica Corp NaviCam Xpress Stomach System 05/04/2021
K230694 AnX Robotica Corp. NaviCam Xpress Stomach System, NaviCam Xpress System 04/13/2023
K231960 AnX Robotica Corporation NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether 10/03/2023
DEN190037 AnX Robotica, Inc. NaviCam Capsule Endoscope System with NaviCam Stomach Capsule 05/22/2020


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