DEN240018 is an FDA 510(k) submission for the CORIS System. This device is classified as a Automated Endoscope Channel Cleaner (Class II - Special Controls, product code SEW).
Submitted by Nanosonics Limited (Macquarie Park, AU). The FDA issued a Not Cleared (DENG) decision on March 19, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6994. An Automated Endoscope Channel Cleaner Is A Device Intended To Replace All Or A Portion Of Manual Cleaning Of Internal Passages And Ports Of Compatible Reusable Flexible Endoscopes. Cleaning Is Conducted Using An Agent That Exerts Physical Force (e.g., Friction) On Single Or Multiple Channels Of Compatible Endoscopes For Removal Of Soil. This Device Type Is Not Intended To Provide Or Replace High-level Disinfection Or Sterilization..
| 510(k) Number | DEN240018 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 01, 2024 |
| Decision Date | March 19, 2025 |
| Days to Decision | 322 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | SEW — Automated Endoscope Channel Cleaner |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6994 |
| Definition | An Automated Endoscope Channel Cleaner Is A Device Intended To Replace All Or A Portion Of Manual Cleaning Of Internal Passages And Ports Of Compatible Reusable Flexible Endoscopes. Cleaning Is Conducted Using An Agent That Exerts Physical Force (e.g., Friction) On Single Or Multiple Channels Of Compatible Endoscopes For Removal Of Soil. This Device Type Is Not Intended To Provide Or Replace High-level Disinfection Or Sterilization. |