Clearance Summary
COOLIEF Cooled Radiofrequency Kit received FDA 510(k) clearance under submission number K163236, sponsored by Halyard Health, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-12-16.
- Submission: K163236
- Applicant / Sponsor: Halyard Health, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4725
- Decision date: 2016-12-16
Classification & Regulation
This clearance is catalogued under FDA product code GXI and 21 CFR 882.4725, within the Neurology review panel as a Class II device.