NGU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Balloon, Liver Tamponade
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIVER TAMPONADE BALLOON (K010450) | Cook, Inc. | 2001-09-06 |
Track NGU automatically
Every clearance here is in the API, with alerts when new ones post.