# K190256: Rulo Radiofrequency Lesion Probe

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: Mar 8, 2019 after 29 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: 10 generations back to K870028 (1987). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141586: Owl Cannulae, Diros Technology, Inc. (2014) Summary page 4.

## Indications for use
The Rulo™ Radiofrequency Lesion Probe is an injection probe which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by 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/K190256
Methodology: https://510kreport.com/methodology