FDA Product Code
FDA Product Code SGY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5881
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN250009 | VitaSmart Hypothermic Oxygenated Perfusion System | Bridge TO Life, Ltd. | 2026-01-15 | Direct | — |
Product code SGY · Class II · Gastroenterology, Urology. Data: openFDA.