# K192491: Coolief Radiofrequency Generator (CRG) System

- Pathway: 510(k) (Traditional)
- Applicant: Avanos Medical, Inc.
- Decided: Feb 21, 2020 after 163 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K031950 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072478: Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TD, Baylis Medical Co., Inc. (2007) Summary page 4.

## Recalls of this device
- Aug 1, 2023 · Class II · Z-2622-2023: Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

## Indications for use
COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.

Source page: https://510kreport.com/device/K192491
Methodology: https://510kreport.com/methodology