K232163
- 510(k) number
- K232163
- Device name
- Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
- Applicant
- Zhejiang Horizon Medical Technology Co., Ltd. CN
- Product code
- MQE — Needle, Assisted Reproduction
- Decision date
- 2024-02-22
- Date received
- 2023-07-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232163.pdf
Official FDA record: K232163
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.