510(k) K163236
K163236 is an FDA 510(k) premarket notification submitted by Halyard Health, Inc. for the device "COOLIEF Cooled Radiofrequency Kit". The FDA issued a decision of Substantially Equivalent on December 16, 2016. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2016
- Date Received
- November 17, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Probe, Radiofrequency Lesion
- Device Class
- Class II
- Regulation Number
- 882.4725
- Review Panel
- NE
- Submission Type