# K080771: Top Neuropole Needle, Model SH, BL, SC, TC

- Pathway: 510(k) (Traditional)
- Applicant: Top Corp.
- Decided: Nov 10, 2008 after 236 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: 7 generations back to K870028 (1987). 15 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 20 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.
- K010202: Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion Probes, Leslie W. Organ (2001) Summary page 1.
- K062946: Top Neuropole Needles, Models ST, X, RC, XE and TL, Top Corp. (2007) Summary page 1.
- K060799: Cosman CSK RF Cannula; Cosman RFK RF Cannula, Cosman Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K102566: Owl Cannulae (2011), 3 descendants of its own
- K141586: Owl Cannulae (2014), 2 descendants of its own
- K190256: Rulo Radiofrequency Lesion Probe (2019), 0 descendants of its own
- K150371: Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH (2015), 0 descendants of its own

## Indications for use
The Top Neuropole Needles are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation 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 solution or a radiofrequency lesion may be made.

Source page: https://510kreport.com/device/K080771
Methodology: https://510kreport.com/methodology