# K994344: Neurotherm RF Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Rocket Medical Plc
- Decided: Mar 21, 2000 after 90 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K053415: Lesionpoint RF Cannula (2006), 10 descendants of its own
- K060799: Cosman CSK RF Cannula; Cosman RFK RF Cannula (2006), 9 descendants of its own
- K080771: Top Neuropole Needle, Model SH, BL, SC, TC (2008), 4 descendants of its own
- K102566: Owl Cannulae (2011), 3 descendants of its own
- K082012: Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CN (2008), 3 descendants of its own

## Indications for use
The Neurotherm Radiofrequency Lesion cannula is indicated for use in neurosurgical lesioning procedures. Examples of these procedures include, but are not limited to, lesioning of nerve fibers for the treatment of pain and lesioning of the brain, spinal cord as in thalamotomies, pallidotomies, cordotomies and hypophysectomies,

Source page: https://510kreport.com/device/K994344
Methodology: https://510kreport.com/methodology