K232163 is an FDA 510(k) clearance for the Lotus Single Lumen Ovum Aspiration Needle. This device is classified as 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 FDA review panel. Regulated under 21 CFR 884.6100.
| 510(k) Number | K232163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2023 |
| Decision Date | February 22, 2024 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQE - Needle, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6100 |