Coolief* Cooled RF Probe— 510(k) K163461

Name: FDA 510(k) clearance K163461
Creator: U.S. Food and Drug Administration
Published: 2017-04-13

Substantially Equivalent

Halyard Health, Inc.

FDA 510(k) clearance K163461 for Coolief* Cooled RF Probe, Substantially Equivalent on 2017-04-13. Applicant: Halyard Health, Inc.. Device class: 2.

Clearance details

Applicant: Halyard Health, Inc.
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2016-12-09
Decision date: 2017-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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K153255 — Aero Chrome* Breathable Performance Surgical Gown2016-04-13
K143095 — MiniStim MS-IVB Peripheral Nerve Stimulator2015-03-24

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.