# K060397: RF Lesion Cannula, RF Thermolesion Cannula, Thermolesion Cannula, X-Ray Contrast Cannula, Cannula, Facet Deneration Need

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Aug 31, 2006 after 197 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: 4 generations back to K870028 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021942: Radionics Pole Needles, Radionics, A Division of Tyco Healthcare Group LP (2002) Summary page 1.
- K032406: Stryker RF Electrodes and Cannulae, Stryker Instruments (2004) Summary page 1.

## Indications for use
Pajunk RFTL Radiofrequency needles are electrically insulated (with lacquer or NanoLine) Cannulas, 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 neuro-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/K060397
Methodology: https://510kreport.com/methodology