510(k) K163461

Coolief* Cooled RF Probe by Halyard Health, Inc. — Product Code GXI

K163461 is an FDA 510(k) premarket notification submitted by Halyard Health, Inc. for the device "Coolief* Cooled RF Probe". The FDA issued a decision of Substantially Equivalent on April 13, 2017. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Halyard Health, Inc. has at least 10 other 510(k) clearances on record.