510(k) K232163

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle by Zhejiang Horizon Medical Technology Co., Ltd. — Product Code MQE

K232163 is an FDA 510(k) premarket notification submitted by Zhejiang Horizon Medical Technology Co., Ltd. for the device "Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle". The FDA issued a decision of Substantially Equivalent on February 22, 2024. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Zhejiang Horizon Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.