510(k) K253267
- Device
- CORIS System
- Applicant
- Nanosonics Limited
- 510(k) number
- K253267
- Product code
- SEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-05
- Date received
- 2025-09-29
- Regulation
- 880.6994
- Classification name
- Automated Endoscope Channel Cleaner
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Nancy Kaiser
- Address
- 7-11 Talavera Rd. Macquarie Park AU 2113 2113
FDA Registration Numbers
- 3008894376
- 3006564498
Source Documents
Other 510(k) Records For Product Code SEW
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN240018 | CORIS System | Nanosonics Limited | 2025-03-19 |