# K201610: IonicRF Generator

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Oct 21, 2020 after 128 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
The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is indicated as an aid in the management of pain in the nervous system. Examples include, facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures.

Source page: https://510kreport.com/device/K201610
Methodology: https://510kreport.com/methodology