# K040565: Physician Industries Radiofrequency Ablation Needle

- Pathway: 510(k) (Traditional)
- Applicant: Physician Industries, Inc.
- Decided: Jul 22, 2004 after 141 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K963577: Radionics Sluijter-Mehta Cannula, Radionics, Inc. (1996) Summary page 1.

## Indications for use
The Physician Industries' Radiofrcquency Ablation Needle is a single use RF (radiofrequency) needle with injection capabilities. It can be used for either 1) radiofrequency (RF) lesioning, or 2) percutaneous nerve blocks with a local anesthetic solution. The nerve is localized by using electrical stimulation through the needle. The nerve may then be blocked either by the generating an RF lesion, or by the injecting of a local anesthetic. It is to be used only under the direction of a licensed clmician.

Source page: https://510kreport.com/device/K040565
Methodology: https://510kreport.com/methodology