CORIS System
FDA 510(k) clearance K253267 · decided 2026-03-05
Clearance details
- K-number
- K253267
- Device name
- CORIS System
- Applicant
- Nanosonics Limited
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2026-03-05
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- SEW
- Device class
- 2
- Regulation number
- 880.6994
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Macquarie Park, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CORIS System (DEN240018) | Nanosonics Limited | 2025-03-19 |
Recalls involving this device
No recalls on record reference this clearance.