510(k) K172344

Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) by Medax Srl Unipersonale — Product Code KNW

K172344 is an FDA 510(k) premarket notification submitted by Medax Srl Unipersonale for the device "Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)". The FDA issued a decision of Substantially Equivalent on Nov 13, 2017. 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.