Instrument, Biopsy, Mechanical, Gastrointestinal
FDA product code FCF · Class II (moderate risk) · 21 CFR 876.1075 · Gastroenterology, Urology
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070759 | Powered Ez-Io Pediatric Bone Marrow Aspiration SystemFCF · Traditional | Vidacare Corporation | 05/21/2007SE |
| K062833 | Powered Ez-Io Bone Marrow Aspiration SystemFCF · Traditional | Vidacare Corporation | 11/30/2006SE |
| K984168 | Barrett's Esophageal Cytology DeviceFCF · Traditional | United States Endoscopy Group, Inc. | 12/07/1999SE |
| K915142 | Amcath Disposable Biopsy ForcepsFCF · Traditional | Intl. Medical, Inc. | 01/10/1992SE |
| K911155 | Oval Cup Biopsy ForcepFCF · Traditional | Endovations | 08/07/1991SE |
| K843477 | Pharma-Plast Rectal TipFCF · Traditional | Zimmar Consulting , Ltd. | 12/05/1984SE |