Clearance Summary
Cellvizio I.V.E. system with Confocal Miniprobes received FDA 510(k) clearance under submission number K212322, sponsored by Mauna Kea Technologies. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2021-08-18.
- Submission: K212322
- Applicant / Sponsor: Mauna Kea Technologies
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2021-08-18
Classification & Regulation
This clearance is catalogued under FDA product code OWN and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.