# K063753: GFX Nerve Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Aci, Inc.
- Decided: Jun 20, 2007 after 183 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K965182 (1997). 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)
- K965182: RFG-3CF, Radionics, Inc. (1997) Summary page 1.
- K000073: Mercury Medical Disposable Radiofrequency Cannula, Mercury Medical (2000) Summary page 1.

## Most influential descendants
- K081729: Modification to GFX Nerve Ablation System (2008), 0 descendants of its own

## Indications for use
The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.

Source page: https://510kreport.com/device/K063753
Methodology: https://510kreport.com/methodology