# K991399: Radionics Microelectrode Kit

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Sep 21, 1999 after 152 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.
28 later devices descend from it; 2 cite it directly.
0 of 29 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 its predicate without a number.
- (no number) TM electrodes: named in the summary without a submission number
- (no number) TCM electrodes: named in the summary without a submission number

## Most influential descendants
- K050084: Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit; (2005), 20 descendants of its own
- 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
- K082051: Cosman G4 Radiofrequency Generator, Model RFG-4 (2008), 7 descendants of its own
- K012850: Recording and Stimulating Electrode (2001), 6 descendants of its own

## Indications for use
For recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures such as but not limited to: cordotomies, tractotomies, myelotomies, thalamotomies and pallidotomies.

Source page: https://510kreport.com/device/K991399
Methodology: https://510kreport.com/methodology