510(k) · Cleared
ClearedDisposable Radiofrequency Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · GXI Probe, Radiofrequency Lesion
Cleared on Apr 16, 2026 as substantially equivalent to K090955 (Smith & Nephew, Inc., 2009) and 2 other predicates after a 132-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Apr 16, 2026
- Review
- 132 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K870028 (1987). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 5 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 4 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 3 generations backK034012 Smith & Nephew RF Denervation Probes & RF CannulaeSmith & Nephew, Inc. · 2004 · Recalled
- 2 generations backK063467 Smith & Nephew RF CannulaeSmith & Nephew, Inc. · 2006
- 1 generation backK090955 Smith & Nephew RF CannulateSmith & Nephew, Inc. · 2009 · Recalled
- This deviceK253907 Disposable Radiofrequency CannulaAbbott Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −5 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −4 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −3 | K034012 | Smith & Nephew RF Denervation Probes & RF Cannulae | Smith & Nephew, Inc. | 2004 | 3 |
| −2 | K063467 | Smith & Nephew RF Cannulae | Smith & Nephew, Inc. | 2006 | — |
| −1 | K090955 | Smith & Nephew RF Cannulate | Smith & Nephew, Inc. | 2009 | 1 |
| 0 (this device) | K253907 | Disposable Radiofrequency Cannula | Abbott Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 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 K251802 STAR RF Ablation Systemscore 11.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K090955 | Smith & Nephew RF CannulateSummary page 5…ion probe Class: II Classification Name: 882.4725 Radiofrequency lesion probe Product Code: GXI Predicate Device 510(k)s: K090955 (Smith & Nephew RF Cannulae) (Primary), K000073 (Mercury Medical Disposable Radiofrequency Cannula),… | 2009 |
| * | K000073 | Mercury Medical Disposable Radiofrequency CannulaSummary page 5…725 Radiofrequency lesion probe Product Code: GXI Predicate Device 510(k)s: K090955 (Smith & Nephew RF Cannulae) (Primary), K000073 (Mercury Medical Disposable Radiofrequency Cannula), K042375 ([Technomed] Disposable Cannula), Refer… | 2000 |
| * | K042375 | SMK, CX, Cxe, RCNSummary page 5…s: K090955 (Smith & Nephew RF Cannulae) (Primary), K000073 (Mercury Medical Disposable Radiofrequency Cannula), K042375 ([Technomed] Disposable Cannula), Reference Device 510(k): K242841 (Disposable RF Electrode) Device Description: Abb… | 2004 |
| † | K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | 2025 |
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 39 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 3 of the 9 ancestors have a recall of any class.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 Disposable Radiofrequency Cannulas, in combination with approved compatible generators and electrodes, are indicated as an aid in the management of pain in the peripheral nervous system. Examples include facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures. These are single-use-only products.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253907: Disposable Radiofrequency Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253907
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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