K023074 is an FDA 510(k) clearance for the IMBIBE BONE MARROW ASPIRATION SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on March 11, 2003, 176 days after receiving the submission on September 16, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K023074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2002 |
| Decision Date | March 11, 2003 |
| Days to Decision | 176 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |