# K111576: NT 2000 Lesioning Generator

- Pathway: 510(k) (Traditional)
- Applicant: Neuro Therm, Inc.
- Decided: Sep 20, 2011 after 106 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K870028 (1987). 12 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052878: NT-1000, Neuro Therm, Inc. (2006) Summary page 1.
- K071482: Stryker RF Multi-Lesion Generator, Model 0406-900-000, Synergetics, Inc. (2007) Summary page 1.
- K082051: Cosman G4 Radiofrequency Generator, Model RFG-4, Cosman Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K232632: Racz Neurostat RF Generator (2024), 0 descendants of its own
- K220122: APEX 6 (2023), 0 descendants of its own
- K201610: IonicRF Generator (2020), 0 descendants of its own

## Recalls of this device
- Sep 28, 2023 · Class II · Z-0209-2024: Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.
- Apr 22, 2021 · Class II · Z-1549-2021: Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.
- Oct 14, 2019 · Class II · Z-0664-2020: Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad wh
- Oct 9, 2013 · Class II · Z-1361-2016: NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States fo

## Indications for use
The NT 2000 is intended for use for lesioning of neural tissue. The NT 2000 is indicated for use in the peripheral nervous system. The NT 2000 is to be used only with FDA cleared NeuroTherm RE probes and Smith & Nephew SPINECATH and ACUTHERM catheters.

Source page: https://510kreport.com/device/K111576
Methodology: https://510kreport.com/methodology