510(k) K010202— OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES

Substantially Equivalent

Leslie W. Organ

Clearance details

Applicant: Leslie W. Organ
Product code: Code GXD
Advisory panel: Neurology
Date received: 2001-01-22
Decision date: 2001-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charleston, SC, US

Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

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.