K170708

Substantially Equivalent

OWL RF INSULATED CANNULAE

Applicant: Diros Technology, Inc.
Product code: GXI
Advisory panel: Neurology
Date received: 2017-03-08
Decision date: 2017-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Markham, CA

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.