FDA Product Code
FDA Product Code SEW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6994
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253267 | CORIS System | Nanosonics Limited | 2026-03-05 | Traditional | PDF ↗ |
| DEN240018 | CORIS System | Nanosonics Limited | 2025-03-19 | Direct | — |
Product code SEW · Class II · General Hospital. Data: openFDA.