K163461 is an FDA 510(k) clearance for the Coolief* Cooled RF Probe. This device is classified as a Probe, Radiofrequency Lesion (Class II - Special Controls, product code GXI).
Submitted by Halyard Health, Inc. (Alpharetta, US). The FDA issued a Cleared decision on April 13, 2017, 125 days after receiving the submission on December 9, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4725.
| 510(k) Number | K163461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2016 |
| Decision Date | April 13, 2017 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXI — Probe, Radiofrequency Lesion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4725 |