K192099 is an FDA 510(k) clearance for the MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Medax Srl Unipersonale (Poggio Rusco, IT). The FDA issued a Cleared decision on April 2, 2020, 241 days after receiving the submission on August 5, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K192099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2019 |
| Decision Date | April 02, 2020 |
| Days to Decision | 241 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 |