510(k) K172051

Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter by Cook Incorporated — Product Code MQF

K172051 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter". The FDA issued a decision of Substantially Equivalent on January 10, 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.