K193416

Substantially Equivalent

Cellvizio I.V.E. with Confocal Miniprobes

Applicant: Mauna Kea Technologies
Product code: OWN
Advisory panel: Gastroenterology, Urology
Date received: 2019-12-09
Decision date: 2020-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

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.