510(k) DEN190037
DEN190037 is an FDA 510(k) premarket notification submitted by Anx Robotica, Inc. for the device "NaviCam Capsule Endoscope System with NaviCam Stomach Capsule". The FDA issued a decision of De Novo Granted on May 22, 2020. The device falls under product code QKZ (Magnetically Maneuvered Capsule Endoscopy System), a Class II device regulated under 21 CFR 876.1310. Anx Robotica, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 22, 2020
- Date Received
- August 13, 2019
- Clearance Type
- Direct
- 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.