510(k) K192099

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 by Medax Srl Unipersonale — Product Code KNW

K192099 is an FDA 510(k) premarket notification submitted by Medax Srl Unipersonale for the device "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". The FDA issued a decision of Substantially Equivalent on Apr 2, 2020. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Medax Srl Unipersonale has 4 other 510(k) clearances on record.