K234023 is an FDA 510(k) clearance for the Oocyte Flushing & Retrieval Medium. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shezhen, CN). The FDA issued a Cleared decision on May 10, 2024, 142 days after receiving the submission on December 20, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K234023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2023 |
| Decision Date | May 10, 2024 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MQL - Media, Reproductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6180 |