Clearance Summary
cryo-GO Vitrification Device received FDA 510(k) clearance under submission number K241341, sponsored by Fujifilm Irvine Scientific. 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 2024-09-26.
- Submission: K241341
- Applicant / Sponsor: Fujifilm Irvine Scientific
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2024-09-26
Classification & Regulation
This clearance is catalogued under FDA product code MQK and 21 CFR 884.6160, within the Obstetrics/Gynecology review panel as a Class II device.