510(k) K173075

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) by Dxnow, Inc. — Product Code MQK

K173075 is an FDA 510(k) premarket notification submitted by Dxnow, Inc. for the device "ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)". The FDA issued a decision of Substantially Equivalent on March 8, 2018. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160.