De Novo DEN240018
- Device
- CORIS System
- Contact
- nancy kaiser
- De Novo number
- DEN240018
- Product code
- SEW
- Regulation
- 880.6994
- Classification name
- automated endoscope channel cleaner
- Decision
- granted (DENG)
- Decision date
- 2025-03-19
- Date received
- 2024-05-01
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- SEW
- Device name
- Automated Endoscope Channel Cleaner
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.6994
- Implant
- N
- Life sustain/support
- N