DEN240018
- 510(k) number
- DEN240018
- Device name
- CORIS System
- Applicant
- Nanosonics Limited AU
- Product code
- SEW — Automated Endoscope Channel Cleaner
- Decision date
- 2025-03-19
- Date received
- 2024-05-01
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General Hospital
Official FDA record: DEN240018
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.