Clearance Summary
PRIME-XV FreezIS DMSO-Free MD received FDA 510(k) clearance under submission number K231804, sponsored by Fujifilm Irvine Scientific. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-11-09.
- Submission: K231804
- Applicant / Sponsor: Fujifilm Irvine Scientific
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5885
- Decision date: 2023-11-09
Classification & Regulation
This clearance is catalogued under FDA product code NDS and 21 CFR 876.5885, within the Gastroenterology, Urology review panel as a Class II device.