OWL CANNULAE— 510(k) K141586

Substantially Equivalent

Diros Technology, Inc.

FDA 510(k) clearance K141586 for OWL CANNULAE, Substantially Equivalent on 2014-12-30. Applicant: Diros Technology, Inc..

Clearance details

Applicant: Diros Technology, Inc.
Product code: Code GXI
Advisory panel: Neurology
Date received: 2014-06-13
Decision date: 2014-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Markham,On, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.