510(k) K231960
K231960 is an FDA 510(k) premarket notification submitted by Anx Robotica Corporation for the device "NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether". The FDA issued a decision of Substantially Equivalent on October 3, 2023. The device falls under product code QKZ (Magnetically Maneuvered Capsule Endoscopy System), a Class II device regulated under 21 CFR 876.1310. Anx Robotica Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2023
- Date Received
- July 3, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Magnetically Maneuvered Capsule Endoscopy System
- Device Class
- Class II
- Regulation Number
- 876.1310
- Review Panel
- GU
- Submission Type
A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.