FIG
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Clamp, Tubing, Blood, Automatic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1992: 1 · 1995: 1 · 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DEKA TAC DEVICE (K093915) | Deka Research & Development Corp. | 2011-08-23 |
| ELS AUTOMATIC TUBING CLAMP SYSTEM (K921993) | Rocky Mountain Research, Inc. | 1994-01-05 |
| AUTOMATIC TUBING CLAMP (K914459) | Rocky Mountain Research, Inc. | 1992-06-24 |
| C-DAK 3500 (K770535) | Cordis Corp. | 1977-04-15 |
Track FIG automatically
Every clearance here is in the API, with alerts when new ones post.