# K081729: Modification to GFX Nerve Ablation System

- Pathway: 510(k) (Special)
- Applicant: Bioform Medical, Inc.
- Decided: Aug 7, 2008 after 50 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: 2 generations back to K965182 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063753: GFX Nerve Ablation System, Aci, Inc. (2007) Summary page 1.
- K965182: RFG-3CF, Radionics, Inc. (1997) Summary page 1.

## 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/K081729
Methodology: https://510kreport.com/methodology