510(k) DEN190037
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.