510(k) · Cleared
ClearedRF Lesion Cannula, RF Thermolesion Cannula, Thermolesion Cannula, X-Ray Contrast Cannula, Cannula, Facet Deneration Need
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · GXI Probe, Radiofrequency Lesion
Cleared on Aug 31, 2006 as substantially equivalent to K021942 (Radionics, A Division of Tyco Healthcare Group LP, 2002) and 1 other predicate after a 197-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Aug 31, 2006
- Review
- 197 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K870028 (1987). 5 ancestors in all. 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 deviceK060397 RF Lesion Cannula, RF Thermolesion Cannula, Thermolesion Cannula…PAJUNK GmbH Medizintechnologie · 2006
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) | K060397 | RF Lesion Cannula, RF Thermolesion Cannula, Thermolesion Cannula, X-Ray… | PAJUNK GmbH Medizintechnologie | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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 GXI? 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 GXI device
- #1 K253907 Disposable Radiofrequency Cannulascore 12.7 · 6 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…e: 21 CFR 882.4725, April 1. 2005 Poposed Classification: Regulatory Class II Proposed Product Code: GXI Predicate Devices: 1. Radionics thermo lesion needles K021942 2. Stryker's RF cannulas K032406 Al K060397 AI-K060397-Thermolesion.doc… | 2002 |
| * | K032406 | Stryker RF Electrodes and CannulaeSummary page 1…Regulatory Class II Proposed Product Code: GXI Predicate Devices: 1. Radionics thermo lesion needles K021942 2. Stryker's RF cannulas K032406 Al K060397 AI-K060397-Thermolesion.doc 2006-06-27… | 2004 |
| † | K000722 | Unipolar Needles | 2000 |
| † | K043130 | Modification to Pajunk Stimulong Plus Catheter Sets | 2004 |
| † | K033018 | Stimulong Plus Catheter Set Model, Various | 2004 |
| † | K042979 | Modification to: Plexalong Sets | 2004 |
| † | K023218 | Modification to Plexolong Sets | 2003 |
| † | K013041 | Plexolong Sets | 2002 |
| † | K053283 | Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set | 2006 |
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 19 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K021942.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXI
183in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXI
98in 2025
MAUDE reports naming product code GXI, 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 | 87 | 3 | 1 |
| 2008 | 2 | — | 1 | 4 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 2 | — | 1 | 8 |
| 2011 | 3 | 64 | 0 | 5 |
| 2012 | 1 | — | 1 | 14 |
| 2013 | 1 | — | 1 | 25 |
| 2014 | 1 | — | 0 | 20 |
| 2015 | 1 | — | 0 | 23 |
| 2016 | 3 | 240 | 0 | 16 |
| 2017 | 3 | 125 | 1 | 150 |
| 2018 | 1 | — | 0 | 147 |
| 2019 | 3 | 63 | 1 | 93 |
| 2020 | 3 | 255 | 0 | 31 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 2 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 35 |
| 2024 | 0 | — | 0 | 45 |
| 2025 | 4 | 183 | 0 | 98 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060397: RF Lesion Cannula, RF Thermolesion Cannula, Thermolesion Cannula, X-Ray Contrast Cannula, Cannula, Facet Deneration Need.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060397
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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