510(k) K162833

VitriGuard by Origio A/S — Product Code MQK

K162833 is an FDA 510(k) premarket notification submitted by Origio A/S for the device "VitriGuard". The FDA issued a decision of Substantially Equivalent on February 16, 2017. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Origio A/S has at least 10 other 510(k) clearances on record.