510(k) DEN240018
- Device
- CORIS System
- Applicant
- Nanosonics Limited
- 510(k) number
- DEN240018
- Product code
- SEW
- Decision
- Unknown (DENG)
- Decision date
- 2025-03-19
- Date received
- 2024-05-01
- Regulation
- 880.6994
- Classification name
- Automated Endoscope Channel Cleaner
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Nancy Kaiser
- Address
- 7-11 Talavera Rd. Macquarie Park AU 2113 2113
FDA Registration Numbers#
- 3008894376
- 3006564498
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SEW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253267 | CORIS System | Nanosonics Limited | 2026-03-05 |