K062833 is an FDA 510(k) clearance for the POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM. This device is classified as a Instrument, Biopsy, Mechanical, Gastrointestinal (Class II - Special Controls, product code FCF).
Submitted by Vidacare Corporation (Irvine, US). The FDA issued a Cleared decision on November 30, 2006, 70 days after receiving the submission on September 21, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K062833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2006 |
| Decision Date | November 30, 2006 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCF — Instrument, Biopsy, Mechanical, Gastrointestinal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |