510(k) · Cleared
ClearedTop Neuropole Needles, Models ST, X, RC, XE and TL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Top Corp. · GXI Probe, Radiofrequency Lesion
Cleared on Feb 15, 2007 as substantially equivalent to K870028 (Radionics, Inc., 1987) after a 140-day review. Its family tree reaches back 1 generation to 1987. 5 later devices descend from it.
- Decided
- Feb 15, 2007
- Review
- 140 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K870028 (1987). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- This deviceK062946 Top Neuropole Needles, Models ST, X, RC, XE and TLTop Corp. · 2007
- Descendant · cites it directly · 4 of its ownK080771 Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008
- Descendant · cites it directly · 3 of its ownK102566 Owl CannulaeDiros Technology, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK141586 Owl CannulaeDiros Technology, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK190256 Rulo Radiofrequency Lesion ProbeEpimed International, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK150371 Diros OWL Sterile Single Use TridentTM R.F. Insulated…Diros Technology, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008 · cites it directly4descendants
- K102566Owl CannulaeDiros Technology, Inc. · 2011 · cites it directly3descendants
- K141586Owl CannulaeDiros Technology, Inc. · 2014 · 2 generations on2descendants
- K190256Rulo Radiofrequency Lesion ProbeEpimed International, Inc. · 2019 · 3 generations on0descendants
- K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRHDiros Technology, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| 0 (this device) | K062946 | Top Neuropole Needles, Models ST, X, RC, XE and TL | Top Corp. | 2007 | — |
| +1 | K080771 | Top Neuropole Needle, Model SH, BL, SC, TC | Top Corp. | 2008 | — |
| +1 | K102566 | Owl Cannulae | Diros Technology, Inc. | 2011 | — |
| +2 | K141586 | Owl Cannulae | Diros Technology, Inc. | 2014 | — |
| +3 | K190256 | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | 2019 | — |
| +2 | K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and… | Diros Technology, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 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? (1)
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…(21 C.F.R. § 882.4725) Product Code: GXI Legally Marketed Device To Which Claim Substantial Equivalence: Radionics (K870028) DEVICE DESCRIPTION Top Neuropole Needles are teflon insulated injection needles for safe thermolesion proced… | 1987 |
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Top Neuropole Needles are injection needles used either for
percutaneous nerve blocks with local anesthetic solution or for
radiofrequency lesioning. A nerve is localized either by using
electrostimulation 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 solution or a radiofrequency
lesion may be made.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062946: Top Neuropole Needles, Models ST, X, RC, XE and TL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062946
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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