# K034012: Smith & Nephew RF Denervation Probes & RF Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 16, 2004 after 83 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). 3 ancestors in all.
15 later devices descend from it; 4 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)
- K870028: SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible, Radionics, Inc. (1987) Summary page 1.
- K980430: Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS), Radionics, Inc. (1998) Summary page 1.

## 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

## Recalls of this device
- Jan 19, 2007 · Not classified · Z-0662-2007: Product is non-sterile but labeled incorrectly as sterile.
- Jan 19, 2007 · Not classified · Z-0663-2007: Product is non-sterile but labeled incorrectly as sterile.
- Jan 19, 2007 · Not classified · Z-0664-2007: Product is non-sterile but labeled incorrectly as sterile.

## Indications for use
The Smith & Nephew RF Denervation Probes and Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

Source page: https://510kreport.com/device/K034012
Methodology: https://510kreport.com/methodology