# K163461: Coolief* Cooled RF Probe

- Pathway: 510(k) (Traditional)
- Applicant: Halyard Health, Inc.
- Decided: Apr 13, 2017 after 125 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: 2 generations back to K002389 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053082: Baylis Pain Management Cooled Probe, Model PMPC-18-150-6, Baylis Medical Co., Inc. (2005) Summary page 5.

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

## Indications for use
The COOLIEF* Cooled Radiofrequency Probe is to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.

Source page: https://510kreport.com/device/K163461
Methodology: https://510kreport.com/methodology