Clearance Summary
Cellvizio 100 Series Systems with Confocal Miniprobes received FDA 510(k) clearance under submission number K180270, sponsored by Mauna Kea Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2018-05-22.
- Submission: K180270
- Applicant / Sponsor: Mauna Kea Technologies
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1480
- Decision date: 2018-05-22
Classification & Regulation
This clearance is catalogued under FDA product code GWG and 21 CFR 882.1480, within the Neurology review panel as a Class II device.