# K232632: Racz Neurostat RF Generator

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International
- Decided: May 24, 2024 after 268 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: 6 generations back to K870028 (1987). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111576: NT 2000 Lesioning Generator, Neuro Therm, Inc. (2011) Summary page 5.

## Indications for use
The Racz Neurostat RF Generator is intended for lesioning of neural tissue. It is indicated for use in the peripheral nervous system. It is to be used with Epimed RF probes and cannula.

Source page: https://510kreport.com/device/K232632
Methodology: https://510kreport.com/methodology