510(k) Report

510(k) · Cleared

Cleared

Lesionpoint RF Cannula

K053415510(k) TraditionalCleared Apr 25, 2006139-day reviewClass II21 CFR 882.4725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cosman Medical, Inc. · GXI Probe, Radiofrequency Lesion

Cleared on Apr 25, 2006 as substantially equivalent to K994344 (Rocket Medical Plc, 2000) and 4 other predicates after a 139-day review. Its family tree reaches back 5 generations to 1987. 10 later devices descend from it.

Decided
Apr 25, 2006
Review
139 days
Class
Class II
Product code
GXI
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K870028 (1987). 12 ancestors in all. 10 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor2002: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor2006: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2011: 1 descendant cleared2008: 2 descendants cleared2015: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant clearedK870028 · SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible · Radionics, Inc. · 1987K963577 · Radionics Sluijter-Mehta Cannula · Radionics, Inc. · 1996K980430 · Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) · Radionics, Inc. · 1998K021942 · Radionics Pole Needles · Radionics, A Division of Tyco Healthcare Group LP · 2002K042375 · SMK, CX, Cxe, RCN · Technomed Europe · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 4 descendants K042375 · SMK, CX, Cxe, RCN · Technomed Europe · 2004K021942 · Radionics Pole Needles · Radionics, A Division of Tyco Healthcare Group LP · 2002K980430 · Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) · Radionics, Inc. · 1998K963577 · Radionics Sluijter-Mehta Cannula · Radionics, Inc. · 1996K870028 · SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible · Radionics, Inc. · 1987−50
  1. Root · 5 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
  2. 4 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
  3. 3 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
  4. 2 generations backK021942 Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
  5. 1 generation backK042375 SMK, CX, Cxe, RCNTechnomed Europe · 2004
  6. This deviceK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
  7. Descendant · cites it directly · 9 of its ownK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
  8. Descendant · 2 generations on · 4 of its ownK080771 Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008
  9. Descendant · 2 generations on · 3 of its ownK102566 Owl CannulaeDiros Technology, Inc. · 2011
  10. Descendant · 2 generations on · 3 of its ownK082012 Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
  11. Descendant · 2 generations on · 2 of its ownK141586 Owl CannulaeDiros Technology, Inc. · 2014

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006: 12008: 22011: 12013: 12014: 12015: 12017: 12019: 12020: 1
2006high 2 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • 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
  • K141586Owl CannulaeDiros Technology, Inc. · 2014 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc.1987—
−4K963577Radionics Sluijter-Mehta CannulaRadionics, Inc.1996—
−3K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc.1998—
−2K021942Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP2002—
−1K042375SMK, CX, Cxe, RCNTechnomed Europe2004—
0 (this device)K053415Lesionpoint RF CannulaCosman Medical, Inc.2006—
+1K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.2006—
+2K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp.2008—
+2K102566Owl CannulaeDiros Technology, Inc.2011—
+2K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc.2008—
+2K141586Owl CannulaeDiros Technology, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200010
200110
200210
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200820
201110
201310
201410
201510
201710
201910
202010
FIG. 1 — Lineage of K053415, 1987–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253907 Disposable Radiofrequency Cannulascore 12.7 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K994344Neurotherm RF Cannula
Summary page 1
…Radiofrequency Lesion Probe, Class II Neurology Devices, Product Code: GXI Predicate Devices: Neurotherm RF Cannula (K994344) Technomed Europe SMK Cannula (K042375) Cosman Medical RF C…
Rocket Medical Plc2000—
*K042375SMK, CX, Cxe, RCN
Summary page 1
…Neurology Devices, Product Code: GXI Predicate Devices: Neurotherm RF Cannula (K994344) Technomed Europe SMK Cannula (K042375) Cosman Medical RF Cannula & TC Electrodes (K050084)…
Technomed Europe2004—
*K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman…
Summary page 1
…Technomed Europe SMK Cannula (K042375) Cosman Medical RF Cannula & TC Electrodes (K050084) Smith & Nephew RE Cannula (K034012) Diros Facet Rhizotomy…
Cosman Medical, Inc.20053
*K034012Smith & Nephew RF Denervation Probes & RF Cannulae
Summary page 1
…Cosman Medical RF Cannula & TC Electrodes (K050084) Smith & Nephew RE Cannula (K034012) Diros Facet Rhizotomy Electrode & Cannula (KO1 0202) D…
Smith & Nephew, Inc.20043
*K010202Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion ProbesLeslie W. Organ2001—

Also cleared against K994344: 3 other devices →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.20069

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 4 companies; a new generation was cleared every 2.1 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • Of its descendants, K060799 (Cosman Medical, Inc., 2006) has gone furthest, with 9 descendants of its own.
  • 3 other devices also cite its predicate K994344.

How does its category compare?

All GXI devices

GXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXI

4in 2025

2007: 42008: 22009: 22010: 22011: 32012: 12013: 12014: 12015: 12016: 32017: 32018: 12019: 32020: 32022: 22025: 42026 (partial year): 2
2007high 4 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXI

183in 2025

2007: 87 days median2011: 64 days median2016: 240 days median2017: 125 days median2019: 63 days median2020: 255 days median2025: 183 days median
2007high 255 (2020) · low 63 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXI

1in 2019

2007: 32008: 12010: 12012: 12013: 12017: 12019: 12026 (partial year): 3
2007high 3 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXI

98in 2025

2007: 12008: 42009: 102010: 82011: 52012: 142013: 252014: 202015: 232016: 162017: 1502018: 1472019: 932020: 312021: 302022: 462023: 352024: 452025: 98
2007high 150 (2017) · low 1 (2007)2025

MAUDE reports naming product code GXI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200748731
20082—14
20092—010
20102—18
201136405
20121—114
20131—125
20141—020
20151—023
20163240016
201731251150
20181—0147
2019363193
20203255031
20210—030
20222—046
20230—035
20240—045
20254183098
20262—3—

What is it indicated for?

The LesionPoint RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain.

Indications for use as stated in the FDA summary.

Also cleared against K994344

3 other devices cite the same predicate.

  • K102566Owl CannulaeDiros Technology, Inc. · 2011
  • K070443Intracept BI-Polar RF Probe, Model 04814Relievant Medsystems, Inc. · 2007
  • K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006

More from Cosman Medical, Inc.

6 FDA decisions under this applicant name. See the company

  • K101131Fiducial MarkersCosman Medical, Inc. · 2010
  • K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
  • K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
  • K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
  • K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal…Cosman Medical, Inc. · 20053 recalls

Recent decisions in GXI

The GXI category page

  • K253907Disposable Radiofrequency CannulaAbbott Medical · 2026
  • K251802STAR RF Ablation SystemMerit Medical Systems, Inc. · 2026
  • K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp. · 2025
  • K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)Abbott Medical · 2025
  • K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve…Stryker Instruments · 2025

https://510kreport.com/device/K053415 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053415: Lesionpoint RF Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053415

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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