K223265 is an FDA 510(k) clearance for the CryoX Vitrification Freeze Kit / Thaw Kit. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Zhejiang Horizon Medical Technology Co., Ltd. (Jiaxing, CN). The FDA issued a Cleared decision on May 11, 2023, 199 days after receiving the submission on October 24, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K223265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2022 |
| Decision Date | May 11, 2023 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6180 |