FCF
6 FDA 510(k) clearances · Product code
90 daysmedian time to decision
382 days90th percentile
6clearances measured
FDA profile
- Official device name
- Instrument, Biopsy, Mechanical, Gastrointestinal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- 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 |
|---|---|---|
| POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM (K070759) | Vidacare Corporation | 2007-05-21 |
| POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM (K062833) | Vidacare Corporation | 2006-11-30 |
| BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE (K984168) | United States Endoscopy Group, Inc. | 1999-12-07 |
| AMCATH DISPOSABLE BIOPSY FORCEPS (K915142) | Intl. Medical, Inc. | 1992-01-10 |
| OVAL CUP BIOPSY FORCEP (K911155) | Endovations | 1991-08-07 |
| PHARMA-PLAST RECTAL TIP (K843477) | Zimmar Consulting , Ltd. | 1984-12-05 |
Track FCF automatically
Every clearance here is in the API, with alerts when new ones post.