Clearance Summary
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) received FDA 510(k) clearance under submission number K241934, sponsored by Anx Robotica Corp. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-07-31.
- Submission: K241934
- Applicant / Sponsor: Anx Robotica Corp
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1310
- Decision date: 2024-07-31
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.