# K050084: Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit;

- Pathway: 510(k) (Traditional)
- Applicant: Cosman Medical, Inc.
- Decided: Mar 17, 2005 after 63 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K870028 (1987). 7 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982489: RFG-3C Plus, Radionics, Inc. (1998) Summary page 1.
- K870028: SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible, Radionics, Inc. (1987) Summary page 1.
- K963577: Radionics Sluijter-Mehta Cannula, Radionics, Inc. (1996) Summary page 1.
- K980430: Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS), Radionics, Inc. (1998) Summary page 1.
- K991399: Radionics Microelectrode Kit, Radionics, Inc. (1999) Summary page 1.
- K021869: Owl Radiofrequency System, Model Urf-2AP, Diros Technology, Inc. (2002) Summary page 1.
- K010202: Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion Probes, Leslie W. Organ (2001) Summary page 1.
- (no number) Radionics SMK Sluijter-Mebta Kit (Preamendment Devices): named in the summary without a submission 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
- K082051: Cosman G4 Radiofrequency Generator, Model RFG-4 (2008), 7 descendants of its own
- K080771: Top Neuropole Needle, Model SH, BL, SC, TC (2008), 4 descendants of its own
- K111576: NT 2000 Lesioning Generator (2011), 3 descendants of its own

## Recalls of this device
- Apr 29, 2026 · Class II · Z-2403-2026: Reusable electrodes may not meet expected performance levels.
- Apr 29, 2026 · Class II · Z-2402-2026: Reusable electrodes may not meet expected performance levels.
- Jul 5, 2017 · Class II · Z-0687-2018: After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood a

## Indications for use
The Cosman Radiofrequency Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes, is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

Source page: https://510kreport.com/device/K050084
Methodology: https://510kreport.com/methodology