# K021942: Radionics Pole Needles

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, A Division of Tyco Healthcare Group LP
- Decided: Sep 11, 2002 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
Longest line of descent: 3 generations back to K870028 (1987). 3 ancestors in all.
15 later devices descend from it; 3 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.
- 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.

## Most influential descendants
- K042375: SMK, CX, Cxe, RCN (2004), 12 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
- K080771: Top Neuropole Needle, Model SH, BL, SC, TC (2008), 4 descendants of its own
- K102566: Owl Cannulae (2011), 3 descendants of its own

## Indications for use
A Pole Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radiofrequency lesion may be made.

Source page: https://510kreport.com/device/K021942
Methodology: https://510kreport.com/methodology