510(k) K191015

Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) by Cook Incorporated — Product Code MQF

K191015 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)". The FDA issued a decision of Substantially Equivalent on May 17, 2019. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Cook Incorporated has at least 10 other 510(k) clearances on record.