# K220122: APEX 6

- Pathway: 510(k) (Traditional)
- Applicant: Rf Innovations, Inc.
- Decided: Mar 15, 2023 after 421 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 4.

## Indications for use
Intended for use for lesioning of neural tissue and for pain management. It is indicated for use in the peripheral nervous system. The APEX 6 is to be used with LCCS electrodes and cannulae and Conmed Thermogard Dispersive Electrodes.

Source page: https://510kreport.com/device/K220122
Methodology: https://510kreport.com/methodology