CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)— 510(k) K133466

Substantially Equivalent

Mauna Kea Technologies

FDA 510(k) clearance K133466 for CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM), Substantially Equivalent on 2014-07-25. Applicant: Mauna Kea Technologies.

Clearance details

Applicant: Mauna Kea Technologies
Product code: Code OWN
Advisory panel: Gastroenterology, Urology
Date received: 2013-11-12
Decision date: 2014-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orinda, CA, US

Download summary PDF View on FDA.gov ↗

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.