FLC
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Station, Dialysis Control, Negative Pressure Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1992: 3 · 1994: 3
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 |
|---|---|---|
| WILSON-COOK DISPOSABLE BIOPSY FORCEPS (K910656) | Wilson-Cook Medical, Inc. | 1991-04-25 |
| FRESENIUS HEMODIALYSIS MACHINE A1008 BSM (K855001) | Seratronics, Inc. | 1986-01-21 |
| NEGATOVE PRESSURE CONVERTOR (K791164) | Medicorp, Inc. | 1979-10-04 |
| COIL MACHINE ADAPTER (K760725) | Gambro, Inc. | 1976-10-27 |
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Every clearance here is in the API, with alerts when new ones post.