De Novo DEN190037
- Device
- NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
- Contact
- david duan
- De Novo number
- DEN190037
- Product code
- QKZ
- Regulation
- 876.1310
- Classification name
- magnetically maneuvered capsule endoscopy system
- Decision
- granted (DENG)
- Decision date
- 2020-05-22
- Date received
- 2019-08-13
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QKZ
- Device name
- Magnetically Maneuvered Capsule Endoscopy System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.1310
- Implant
- N
- Life sustain/support
- N