K253267 is an FDA 510(k) clearance 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 Cleared decision on March 5, 2026, 157 days after receiving the submission on September 29, 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 | K253267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2025 |
| Decision Date | March 05, 2026 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |