# K163236: COOLIEF Cooled Radiofrequency Kit

- Pathway: 510(k) (Traditional)
- Applicant: Halyard Health, Inc.
- Decided: Dec 16, 2016 after 29 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002389 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062937: Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-Ppu, Baylis Medical Co., Inc. (2007) Summary page 5.

## Most influential descendants
- K203066: COOLIEF Cooled Radiofrequency Kit Advanced (2020), 0 descendants of its own

## Indications for use
The HALYARD* COOLIEF* Cooled Radiofrequency Kit, in combination with the HALYARD* Radiofrequency (RF) Generator (PMG-BASIC/PMG-ADVANCED) (formerly Baylis Pain Management Generator or KIMBERLY-CLARK® Pain Management Generator) is intended for the creation of Radio-Frequency (RF) heat lesions in nervous tissue for the relief of pain, and includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.

Source page: https://510kreport.com/device/K163236
Methodology: https://510kreport.com/methodology