Clearance Summary
Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle received FDA 510(k) clearance under submission number K232163, sponsored by Zhejiang Horizon Medical Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2024-02-22.
- Submission: K232163
- Applicant / Sponsor: Zhejiang Horizon Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6100
- Decision date: 2024-02-22
Classification & Regulation
This clearance is catalogued under FDA product code MQE and 21 CFR 884.6100, within the Obstetrics/Gynecology review panel as a Class II device.