Clearance Summary
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 received FDA 510(k) clearance under submission number K221608, sponsored by Anx Robotica Corp. 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 2022-11-22.
- Submission: K221608
- Applicant / Sponsor: Anx Robotica Corp
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1310
- Decision date: 2022-11-22
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.