Clearance Summary
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether received FDA 510(k) clearance under submission number K231960, sponsored by Anx Robotica Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-10-03.
- Submission: K231960
- Applicant / Sponsor: Anx Robotica Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1310
- Decision date: 2023-10-03
Classification & Regulation
This clearance is catalogued under FDA product code QKZ and 21 CFR 876.1310, within the Gastroenterology, Urology review panel as a Class II device.