Clearance Summary
Dewin Blastocyst Medium (with HSA and without HSA) received FDA 510(k) clearance under submission number K231370, sponsored by Donnevie Medical Technology (Shanghai) Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2023-08-04.
- Submission: K231370
- Applicant / Sponsor: Donnevie Medical Technology (Shanghai) Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2023-08-04
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.