510(k) K220010

Daylily Single Use Sterile Embryo Transfer Catheter by Shanghai Horizon Medical Technology Co., Ltd. — Product Code MQF

K220010 is an FDA 510(k) premarket notification submitted by Shanghai Horizon Medical Technology Co., Ltd. for the device "Daylily Single Use Sterile Embryo Transfer Catheter". The FDA issued a decision of Substantially Equivalent on December 16, 2022. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110.