510(k) · Cleared
ClearedTop Neuropole Needle, Model SH, BL, SC, TC
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 Nov 10, 2008 as substantially equivalent to K870028 (Radionics, Inc., 1987) and 4 other predicates after a 236-day review. Its family tree reaches back 7 generations to 1987. 4 later devices descend from it.
- Decided
- Nov 10, 2008
- Review
- 236 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K870028 (1987). 15 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 6 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 5 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 4 generations backK021942 Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
- 3 generations backK042375 SMK, CX, Cxe, RCNTechnomed Europe · 2004
- 2 generations backK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
- 1 generation backK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
- This deviceK080771 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 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −7 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −6 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −5 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −4 | K021942 | Radionics Pole Needles | Radionics, A Division of Tyco Healthcare Group LP | 2002 | — |
| −3 | K042375 | SMK, CX, Cxe, RCN | Technomed Europe | 2004 | — |
| −2 | K053415 | Lesionpoint RF Cannula | Cosman Medical, Inc. | 2006 | — |
| −1 | K060799 | Cosman CSK RF Cannula; Cosman RFK RF Cannula | Cosman Medical, Inc. | 2006 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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, K980430, K010202 Top: K062946 Cosman: K060799 DEV… | 1987 |
| * | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Summary page 1…R. § 882.4725) Product Code: GXI Legally Marketed Device To Which Claim Substantial Equivalence: Radionics: K870028, K980430, K010202 Top: K062946 Cosman: K060799 DEVICE DESCR… | 1998 |
| * | K010202 | Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion ProbesSummary page 1…4725) Product Code: GXI Legally Marketed Device To Which Claim Substantial Equivalence: Radionics: K870028, K980430, K010202 Top: K062946 Cosman: K060799 DEVICE DESCRIPTION… | 2001 |
| * | K062946 | Top Neuropole Needles, Models ST, X, RC, XE and TLSummary page 1…egally Marketed Device To Which Claim Substantial Equivalence: Radionics: K870028, K980430, K010202 Top: K062946 Cosman: K060799 DEVICE DESCRIPTION Top Neuropole Needles are injection needles… | 2007 |
| * | K060799 | Cosman CSK RF Cannula; Cosman RFK RF CannulaSummary page 1…alence: Radionics: K870028, K980430, K010202 Top: K062946 Cosman: K060799 DEVICE DESCRIPTION Top Neuropole Needles are injection needles which are used for temperature controlled radi… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102566 | Owl Cannulae | 2011 | 3 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K102566 (Diros Technology, Inc., 2011) has gone furthest, with 3 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. 2008, 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 which may be 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/K080771 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080771: Top Neuropole Needle, Model SH, BL, SC, TC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080771
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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