510(k) K173686

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter by Cook Incorporated — Product Code MQF

K173686 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter". The FDA issued a decision of Substantially Equivalent on April 11, 2018. 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.