About This 510(k) Submission
K232163 is an FDA 510(k) clearance for the Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle, a Needle, Assisted Reproduction (Class II — Special Controls, product code MQE), submitted by Zhejiang Horizon Medical Technology Co., Ltd. (Jiaxing, CN). The FDA issued a Cleared decision on February 22, 2024, 216 days after receiving the submission on July 21, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6100.