510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit;

K050084510(k) TraditionalCleared Mar 17, 200563-day reviewClass II21 CFR 882.4725Recalls 3

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 Mar 17, 2005 as substantially equivalent to K982489 (Radionics, Inc., 1998) and 6 other predicates after a 63-day review. Its family tree reaches back 3 generations to 1987. 20 later devices descend from it. It has been recalled 3 times.

Decided
Mar 17, 2005
Review
63 days
Class
Class II
Product code
GXI
Recalls
3
Predicates
7

Its longest line of descent runs back 3 generations to K870028 (1987). 7 ancestors in all. 20 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor2006: 2 descendants cleared2008: 3 descendants cleared2025: 2 descendants cleared2019: 2 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2011: 2 descendants cleared2023: 2 descendants cleared2015: 1 descendant cleared2020: 2 descendants cleared2024: 1 descendant cleared2017: 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. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 6 descendants2 generations forward: 7 descendants3 generations forward: 7 descendants K980430 · 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. · 19870
  1. Root · 3 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
  2. 2 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
  3. 1 generation backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
  4. This deviceK050084 Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal…Cosman Medical, Inc. · 2005
  5. Descendant · cites it directly · 10 of its ownK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
  6. Descendant · cites it directly · 9 of its ownK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
  7. Descendant · cites it directly · 7 of its ownK082051 Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
  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 ownK111576 NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 2011 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2006: 22008: 32011: 22013: 12014: 12015: 12017: 12019: 22020: 22023: 22024: 12025: 2
2006high 3 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 20 · See all
  • K053415Lesionpoint RF CannulaCosman Medical, Inc. · 2006 · cites it directly10descendants
  • K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006 · cites it directly9descendants
  • K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008 · cites it directly7descendants
  • K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008 · 2 generations on4descendants
  • K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 2011 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc.1987—
−2K963577Radionics Sluijter-Mehta CannulaRadionics, Inc.1996—
−1K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc.1998—
0 (this device)K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit…Cosman Medical, Inc.2005—
+1K053415Lesionpoint RF CannulaCosman Medical, Inc.2006—
+1K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.2006—
+1K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc.2008—
+2K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp.2008—
+2K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc.20114

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200830
201120
201310
201410
201510
201710
201920
202020
202320
202410
202520
FIG. 1 — Lineage of K050084, 1987–2025Source: 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? (8)

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
*K982489RFG-3C Plus
Summary page 1
…er section 513(b) of the Food, Drug, and Cosmetic Act. Predicate Devices: Radionics, RFG-3C Plus Lesion Generator (K982489) Radionics SMK Sluijter-Mebta Kit (K(870028, K963…
Radionics, Inc.1998—
*K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible
Summary page 1
…tic Act. Predicate Devices: Radionics, RFG-3C Plus Lesion Generator (K982489) Radionics SMK Sluijter-Mebta Kit (K(870028, K963577,K980430 and Preamendment Devices) Radion…
Radionics, Inc.1987—
*K963577Radionics Sluijter-Mehta Cannula
Summary page 1
…onics, RFG-3C Plus Lesion Generator (K982489) Radionics SMK Sluijter-Mebta Kit (K(870028, K963577,K980430 and Preamendment Devices) Radionics Microelectrode Kit (K99 1399)…
Radionics, Inc.1996—
*K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)
Summary page 1
…FG-3C Plus Lesion Generator (K982489) Radionics SMK Sluijter-Mebta Kit (K(870028, K963577,K980430 and Preamendment Devices) Radionics Microelectrode Kit (K99 1399)…
Radionics, Inc.1998—
*K991399Radionics Microelectrode Kit
Summary page 1
…ta Kit (K(870028, K963577,K980430 and Preamendment Devices) Radionics Microelectrode Kit (K99 1399) Diros Technology URF-2AP Lesion Generator (K(021869) D…
Radionics, Inc.1999—
*K021869Owl Radiofrequency System, Model Urf-2AP
Summary page 1
…t Devices) Radionics Microelectrode Kit (K99 1399) Diros Technology URF-2AP Lesion Generator (K(021869) Diros Technology URP-2A and Associated Radiofrequency…
Diros Technology, Inc.2002—
*K010202Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion Probes
Summary page 1
…Lesion Generator (K(021869) Diros Technology URP-2A and Associated Radiofrequency Probes (K010202) Intended Use: The CosmanRBLesion GeneratorModel REG-lAand associated Radiofrequency Lesion Probes, is indicated for use in proc…
Leslie W. Organ2001—
*—Radionics SMK Sluijter-Mebta Kit (Preamendment Devices)
Named without a submission number
—

Also cleared against K982489: 3 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K053415Lesionpoint RF CannulaCosman Medical, Inc.200610
K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.20069
K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc.20087
K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc.20083
K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.20250
K183177Nitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation20190

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 29, 2026Class IIZ-2403-2026Under Investigation by firmReusable electrodes may not meet expected performance levels.
Apr 29, 2026Class IIZ-2402-2026Under Investigation by firmReusable electrodes may not meet expected performance levels.
Jul 5, 2017Class IIZ-0687-2018Device DesignAfter multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K053415 (Cosman Medical, Inc., 2006) has gone furthest, with 10 descendants of its own.
  • 3 other devices also cite its predicate K982489.

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 Radiofrequency Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes, is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K982489

3 other devices cite the same predicate.

  • K101592Erase Hand- Held Controller; Erase Single Use Electric Catridge SystemCheng Medical, Corporation · 2011
  • K033981Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004
  • K021329Rita SystemRita Medical Systems · 2002

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
  • K053415Lesionpoint RF CannulaCosman Medical, Inc. · 2006

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/K050084 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050084: Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050084

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