EZ-BLOCKER— 510(k) K121462

Substantially Equivalent

Ez-Blocker B.V.

FDA 510(k) clearance K121462 for EZ-BLOCKER, Substantially Equivalent on 2012-09-28. Applicant: Ez-Blocker B.V..

Clearance details

Applicant: Ez-Blocker B.V.
Product code: Code CBI
Advisory panel: Anesthesiology
Date received: 2012-05-17
Decision date: 2012-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

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.