510(k) · Cleared
ClearedLCCS Disposable RF Electrode, LCCS Reusable RF Electrode
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 Aug 26, 2016 as substantially equivalent to K110593 (Diros Technology, Inc., 2011) and 1 other predicate after a 346-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Aug 26, 2016
- Review
- 346 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010202 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010202 | Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion… | Leslie W. Organ | 2001 | — |
| −1 | K110593 | Owl RF Probes | Diros Technology, Inc. | 2011 | — |
| 0 (this device) | K152642 | LCCS Disposable RF Electrode, LCCS Reusable RF Electrode | Lccs Products Limited | 2016 | — |
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 |
|---|---|---|---|
| * | K110593 | Owl RF ProbesSummary page 4…Regulation No. 882.4725 3. Legally Marketed Predicate Device Trade Name OWL Sterile Single Use RF Probes 510(k) Number K110593 Product Code GXI Manufacturer Diros Technology Inc.… | 2011 |
| * | K010202 | Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion ProbesSummary page 5…510(k) Summary Product: LCCS RF Electrode Trade Name OWL Reusable RF Probes 510(k) Number K010202 Product Code GXI Manufacturer Diros Technology Inc. 4. Device Description LCCS Radiof… | 2001 |
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 15 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
LCCS Radiofrequency (RF) Electrode is indicated for use in temperature-controlled RF heat lesion procedures of peripheral nerve tissue for the relief of pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152642: LCCS Disposable RF Electrode, LCCS Reusable RF Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152642
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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