510(k) DEN240018
DEN240018 is an FDA 510(k) premarket notification submitted by Nanosonics Limited for the device "CORIS System". The FDA issued a decision of De Novo Granted on Mar 19, 2025. The device falls under product code SEW (Automated Endoscope Channel Cleaner), a Class II device regulated under 21 CFR 880.6994. Nanosonics Limited has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Mar 19, 2025
- Date Received
- May 1, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Endoscope Channel Cleaner
- Device Class
- Class II
- Regulation Number
- 880.6994
- Review Panel
- HO
- Submission Type
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.