Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH— 510(k) K150371

Substantially Equivalent

Diros Technology, Inc.

FDA 510(k) clearance K150371 for Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH, Substantially Equivalent on 2015-07-30. Applicant: Diros Technology, Inc..

Clearance details

Applicant: Diros Technology, Inc.
Product code: Code GXI
Advisory panel: Neurology
Date received: 2015-02-13
Decision date: 2015-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Markham, 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.