K230015 is an FDA 510(k) clearance for the OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Laurane Medical Sas (Le Pradet, FR). The FDA issued a Cleared decision on June 16, 2023, 164 days after receiving the submission on January 3, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K230015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2023 |
| Decision Date | June 16, 2023 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |