COOLIEF Cooled Radiofrequency Kit— 510(k) K163236

Substantially Equivalent

Halyard Health, Inc.

FDA 510(k) clearance K163236 for COOLIEF Cooled Radiofrequency Kit, Substantially Equivalent on 2016-12-16. Applicant: Halyard Health, Inc..

Clearance details

Applicant: Halyard Health, Inc.
Product code: Code GXI
Advisory panel: Neurology
Date received: 2016-11-17
Decision date: 2016-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

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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.