510(k) Report

510(k) · Cleared

Cleared

Cosman CSK RF Cannula; Cosman RFK RF Cannula

K060799510(k) TraditionalCleared May 2, 200639-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 May 2, 2006 as substantially equivalent to K053415 (Cosman Medical, Inc., 2006) and 4 other predicates after a 39-day review. Its family tree reaches back 6 generations to 1987. 9 later devices descend from it.

Decided
May 2, 2006
Review
39 days
Class
Class II
Product code
GXI
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K870028 (1987). 13 ancestors in all. 9 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2000: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor2013: 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 · 2004K053415 · Lesionpoint RF Cannula · Cosman Medical, Inc. · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors 1 generation forward: 5 descendants2 generations forward: 4 descendants K053415 · Lesionpoint RF Cannula · Cosman Medical, Inc. · 2006K042375 · 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 · 6 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
  2. 5 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
  3. 4 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
  4. 3 generations backK021942 Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
  5. 2 generations backK042375 SMK, CX, Cxe, RCNTechnomed Europe · 2004
  6. 1 generation backK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
  7. This deviceK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
  8. Descendant · cites it directly · 4 of its ownK080771 Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008
  9. Descendant · cites it directly · 3 of its ownK102566 Owl CannulaeDiros Technology, Inc. · 2011
  10. Descendant · cites it directly · 3 of its ownK082012 Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
  11. Descendant · cites it directly · 2 of its ownK141586 Owl CannulaeDiros Technology, Inc. · 2014
  12. Descendant · cites it directly · 2 of its ownK123178 Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div. · 2013

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2008: 22011: 12013: 12014: 12015: 12017: 12019: 12020: 1
2008high 2 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 9 · See all
  • K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008 · cites it directly4descendants
  • K102566Owl CannulaeDiros Technology, Inc. · 2011 · cites it directly3descendants
  • K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008 · cites it directly3descendants
  • K141586Owl CannulaeDiros Technology, Inc. · 2014 · cites it directly2descendants
  • K123178Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div. · 2013 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc.1987—
−5K963577Radionics Sluijter-Mehta CannulaRadionics, Inc.1996—
−4K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc.1998—
−3K021942Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP2002—
−2K042375SMK, CX, Cxe, RCNTechnomed Europe2004—
−1K053415Lesionpoint RF CannulaCosman Medical, Inc.2006—
0 (this device)K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.2006—
+1K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp.2008—
+1K102566Owl CannulaeDiros Technology, Inc.2011—
+1K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc.2008—
+1K141586Owl CannulaeDiros Technology, Inc.2014—
+1K123178Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div.2013—

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
200820
201110
201310
201410
201510
201710
201910
202010
FIG. 1 — Lineage of K060799, 1987–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K053415Lesionpoint RF Cannula
Cleared while this submission was under review
Summary page 1
…2.4725, Radiofrequency Lesion Probe, Class II Neurology Devices, Product Code: GXI Predicate Devices: LesionPoint RF Cannula (K053415) Neurotherm RF Cannula (K994344) Technomed Europe SMK Cannula (K042…
Cosman Medical, Inc.2006—
*K994344Neurotherm RF Cannula
Summary page 1
…Class II Neurology Devices, Product Code: GXI Predicate Devices: LesionPoint RF Cannula (K053415) Neurotherm RF Cannula (K994344) Technomed Europe SMK Cannula (K042375) Cosman Medical RF Cannula &…
Rocket Medical Plc2000—
*K042375SMK, CX, Cxe, RCN
Summary page 1
…LesionPoint RF Cannula (K053415) 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 RF Cannula (K034012) Diros Facet Rhizotomy Electrod…
Cosman Medical, Inc.20053
*K034012Smith & Nephew RF Denervation Probes & RF Cannulae
Summary page 1
…Cosman Medical RF Cannula & TC Electrodes (K050084) Smith & Nephew RF Cannula (K034012) Diros Facet Rhizotomy Electrode & Cannula (KG10202) Descripti…
Smith & Nephew, Inc.20043
Kept off the family treeK010202FDA’s K010202 is Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion…
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Leslie W. Organ2001—

What descends from it? (9)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp.20084
K102566Owl CannulaeDiros Technology, Inc.20113
K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc.20083
K141586Owl CannulaeDiros Technology, Inc.20142
K123178Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div.20132

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 13 ancestors have a recall of any class.
  • Of its descendants, K080771 (Top Corp., 2008) has gone furthest, with 4 descendants of its own.

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 Cosman 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.

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
  • K053415Lesionpoint 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/K060799 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060799: Cosman CSK RF Cannula; Cosman RFK RF Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060799

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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