510(k) · Cleared
ClearedCosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosman Medical, Inc. · GXI Probe, Radiofrequency Lesion
Cleared on Oct 14, 2008 as substantially equivalent to K042375 (Technomed Europe, 2004) and 2 other predicates after a 91-day review. Its family tree reaches back 7 generations to 1987. 3 later devices descend from it.
- Decided
- Oct 14, 2008
- Review
- 91 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K870028 (1987). 14 ancestors in all. 3 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 deviceK082012 Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK123178 Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div. · 2013
- Descendant · 2 generations on · 0 of its ownK191293 LCCS VC-S RF CannulaLccs Products Limited · 2020
- Descendant · 2 generations on · 0 of its ownK170242 MultiGen™ 2 RF Generator SystemStryker Corporation · 2017
Most influential descendants
Showing 3 of 3 · See all- K123178Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div. · 2013 · cites it directly2descendants
- K191293LCCS VC-S RF CannulaLccs Products Limited · 2020 · 2 generations on0descendants
- K170242MultiGen™ 2 RF Generator SystemStryker Corporation · 2017 · 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) | K082012 | Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CN | Cosman Medical, Inc. | 2008 | — |
| +1 | K123178 | Stryker Venom Electrodes and Cannulae | Stryker Instruments, Instruments Div. | 2013 | — |
| +2 | K191293 | LCCS VC-S RF Cannula | Lccs Products Limited | 2020 | — |
| +2 | K170242 | MultiGen™ 2 RF Generator System | Stryker Corporation | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K042375 | SMK, CX, Cxe, RCNSummary page 1…Probe Class II Neurology Devices, Product Code: GXI Predicate Devices: Technomed Europe RE Injection Needles(K042375) Cosman Medical TC Electrodes (K050084) Cosmnan M… | 2004 |
| * | K050084 | Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman…Summary page 1…ct Code: GXI Predicate Devices: Technomed Europe RE Injection Needles(K042375) Cosman Medical TC Electrodes (K050084) Cosmnan Medical RE Cannula (K060799) Device Description: The Cosman RE Injection Electr… | 2005 |
| * | K060799 | Cosman CSK RF Cannula; Cosman RFK RF CannulaSummary page 1…ction Needles(K042375) Cosman Medical TC Electrodes (K050084) Cosmnan Medical RE Cannula (K060799) Device Description: The Cosman RE Injection Electrodes are used in conjunction with the commercially available Cosman RE Genera… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123178 | Stryker Venom Electrodes and Cannulae | 2013 | 2 |
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 4 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K123178 (Stryker Instruments, Instruments Div., 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K042375.
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 Cosman RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082012: Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082012
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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