510(k) · Cleared
ClearedLCCS VC-S RF Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lccs Products Limited · GXI Probe, Radiofrequency Lesion
Cleared on Jan 24, 2020 as substantially equivalent to K112231 (Lccs Products Limited, 2011) and 1 other predicate after a 255-day review. Its family tree reaches back 9 generations to 1987.
- Decided
- Jan 24, 2020
- Review
- 255 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K870028 (1987). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 5 generations between
- 3 generations backK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
- 2 generations backK082012 Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
- 1 generation backK123178 Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div. · 2013
- This deviceK191293 LCCS VC-S RF CannulaLccs Products Limited · 2020
Show all 9 generations
- Root · 9 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 8 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 7 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 6 generations backK021942 Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
- 5 generations backK042375 SMK, CX, Cxe, RCNTechnomed Europe · 2004
- 4 generations backK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
- 3 generations backK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
- 2 generations backK082012 Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
- 1 generation backK123178 Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div. · 2013
- This deviceK191293 LCCS VC-S RF CannulaLccs Products Limited · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −8 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −7 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −6 | K021942 | Radionics Pole Needles | Radionics, A Division of Tyco Healthcare Group LP | 2002 | — |
| −5 | K042375 | SMK, CX, Cxe, RCN | Technomed Europe | 2004 | — |
| −4 | K053415 | Lesionpoint RF Cannula | Cosman Medical, Inc. | 2006 | — |
| −3 | K060799 | Cosman CSK RF Cannula; Cosman RFK RF Cannula | Cosman Medical, Inc. | 2006 | — |
| −2 | 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 | — |
| 0 (this device) | K191293 | LCCS VC-S RF Cannula | Lccs Products Limited | 2020 | — |
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 | 2 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K112231 | LCCS Insulated Spinal Needle (RF Cannula)Summary page 4…obe, Radiofrequency Lesion 4. Predicate Devices: Predicate Device 510 (k) Predicate Device name number K112231 LCCS Insulated Spinal Needle (RF Cannula) K123178 Stryker® Venom™ Electrodes an… | 2011 |
| * | K123178 | Stryker Venom Electrodes and CannulaeSummary page 4…Predicate Device name number K112231 LCCS Insulated Spinal Needle (RF Cannula) K123178 Stryker® Venom™ Electrodes and Cannulae 5. Device Description: The LCCS VC-S RF Cannula is used in conjunct… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate K112231.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 LCCS VC-S RF Cannula is intended for use in RF heat lesion procedures for
the relief of pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191293: LCCS VC-S 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/K191293
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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