K220010 is an FDA 510(k) clearance for the Daylily Single Use Sterile Embryo Transfer Catheter. This device is classified as a Catheter, Assisted Reproduction (Class II - Special Controls, product code MQF).
Submitted by Shanghai Horizon Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 16, 2022, 346 days after receiving the submission on January 4, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6110.
| 510(k) Number | K220010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2022 |
| Decision Date | December 16, 2022 |
| Days to Decision | 346 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQF - Catheter, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6110 |