510(k) · Cleared
Recalled · 2007Smith & Nephew RF Denervation Probes & RF Cannulae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GXI Probe, Radiofrequency Lesion
Cleared on Mar 16, 2004 as substantially equivalent to K870028 (Radionics, Inc., 1987) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 1987. 15 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 16, 2004
- Review
- 83 days
- Class
- Class II
- Product code
- GXI
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K870028 (1987). 15 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 2 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 1 generation backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- This deviceK034012 Smith & Nephew RF Denervation Probes & RF CannulaeSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK080771 Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008
- Descendant · 2 generations on · 3 of its ownK102566 Owl CannulaeDiros Technology, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK082012 Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K053415Lesionpoint RF CannulaCosman Medical, Inc. · 2006 · cites it directly10descendants
- K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006 · cites it directly9descendants
- K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008 · 2 generations on4descendants
- K102566Owl CannulaeDiros Technology, Inc. · 2011 · 2 generations on3descendants
- K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −2 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −1 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| 0 (this device) | K034012 | Smith & Nephew RF Denervation Probes & RF Cannulae | Smith & Nephew, Inc. | 2004 | — |
| +1 | K053415 | Lesionpoint RF Cannula | Cosman Medical, Inc. | 2006 | — |
| +1 | K060799 | Cosman CSK RF Cannula; Cosman RFK RF Cannula | Cosman Medical, Inc. | 2006 | — |
| +2 | K080771 | Top Neuropole Needle, Model SH, BL, SC, TC | Top Corp. | 2008 | — |
| +2 | K102566 | Owl Cannulae | Diros Technology, Inc. | 2011 | — |
| +2 | K082012 | Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CN | Cosman Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleSummary page 1…and fundamental scientific technology to the following legally marketed devices in commercial distribution: Radionics; Racz-Finch Electrode and RFK Needles (K870028 and K980430). S & N - RF… | 1987 |
| * | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Summary page 1…undamental scientific technology to the following legally marketed devices in commercial distribution: Radionics; Racz-Finch Electrode and RFK Needles (K870028 and K980430). S & N - RF Denervation… | 1998 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2007 | Not classified | Z-0662-2007 | Other | Product is non-sterile but labeled incorrectly as sterile. |
| Jan 19, 2007 | Not classified | Z-0663-2007 | Other | Product is non-sterile but labeled incorrectly as sterile. |
| Jan 19, 2007 | Not classified | Z-0664-2007 | Other | Product is non-sterile but labeled incorrectly as sterile. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K053415 (Cosman Medical, Inc., 2006) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K870028.
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?
The Smith & Nephew RF Denervation Probes and Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034012 · printed Nov 3, 2026
Cite this page
510(k) Report. “K034012: Smith & Nephew RF Denervation Probes & RF Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K034012
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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