510(k) K180270— Cellvizio 100 Series Systems with Confocal Miniprobes

Substantially Equivalent

Mauna Kea Technologies

Clearance details

Applicant: Mauna Kea Technologies
Product code: Code GWG
Advisory panel: Neurology
Date received: 2018-01-31
Decision date: 2018-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.