# K052878: NT-1000

- Pathway: 510(k) (Traditional)
- Applicant: Neuro Therm, Inc.
- Decided: Jan 23, 2006 after 103 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
No predicates in its family tree.
18 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K082051: Cosman G4 Radiofrequency Generator, Model RFG-4 (2008), 7 descendants of its own
- K071482: Stryker RF Multi-Lesion Generator, Model 0406-900-000 (2007), 5 descendants of its own
- K061660: Stryker RF Parallel Bipolar Adaptor Cable (2006), 5 descendants of its own
- K083528: Smith & Nephew Bipolar Adapter Cable, Model 72200022 (2009), 4 descendants of its own
- K111262: Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters, Bipolar Electrosurgical Cables, Monop (2012), 3 descendants of its own

## Indications for use
The NT 1000 is intended for use to create lesions in neural tissue. The NT 1000 is to be used with separately approved lesion/temperature probes such as NeuroTherm radiofrequency probes, Smith & Nephew SpinecathTM and AcuthermTM catheters, and Radionics DiskTrodeTM radiofrequency probes.

Source page: https://510kreport.com/device/K052878
Methodology: https://510kreport.com/methodology