510(k) · Cleared
ClearedPhysician Industries Radiofrequency Ablation Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physician Industries, Inc. · GXD Generator, Lesion, Radiofrequency
Cleared on Jul 22, 2004 as substantially equivalent to K021942 (Radionics, A Division of Tyco Healthcare Group LP, 2002) and 1 other predicate after a 141-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Jul 22, 2004
- Review
- 141 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K870028 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 3 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 2 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 1 generation backK021942 Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
- This deviceK040565 Physician Industries Radiofrequency Ablation NeedlePhysician Industries, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −3 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −2 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −1 | K021942 | Radionics Pole Needles | Radionics, A Division of Tyco Healthcare Group LP | 2002 | — |
| 0 (this device) | K040565 | Physician Industries Radiofrequency Ablation Needle | Physician Industries, Inc. | 2004 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXD device
- #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021942 | Radionics Pole NeedlesSummary page 1…Needle Classification: UXI; GXD Regulation Nos.: 882.4775; 882.4400 02. PREDICATE DEVICES: * Radionics' Pole Needle, K02 1942, found SE Sepl11,2002); * Radionics' Pole Needle, K963577, found SE Nov. 21, 1996 * See also… | 2002 |
| * | K963577 | Radionics Sluijter-Mehta CannulaSummary page 1…82.4775; 882.4400 02. PREDICATE DEVICES: * Radionics' Pole Needle, K02 1942, found SE Sepl11,2002); * Radionics' Pole Needle, K963577, found SE Nov. 21, 1996 * See also the FDA's5 10(k) database of several other products under the same… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K021942.
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXD
185in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXD
88in 2025
MAUDE reports naming product code GXD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 185 | 0 | 10 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 1 | — | 1 | 69 |
| 2011 | 2 | — | 0 | 89 |
| 2012 | 0 | — | 0 | 77 |
| 2013 | 0 | — | 0 | 119 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 67 |
| 2016 | 0 | — | 1 | 51 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 156 |
| 2019 | 1 | — | 1 | 195 |
| 2020 | 2 | — | 0 | 138 |
| 2021 | 0 | — | 0 | 154 |
| 2022 | 1 | — | 0 | 84 |
| 2023 | 2 | — | 1 | 54 |
| 2024 | 2 | — | 0 | 63 |
| 2025 | 1 | — | 0 | 88 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040565: Physician Industries Radiofrequency Ablation Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040565
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026