510(k) · Cleared
ClearedConcerto Bipolar Needle Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 13, 2006 after a 24-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 13, 2006
- Review
- 24 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK060419 Concerto Bipolar Needle ElectrodeBoston Scientific Corp · 2006
- Descendant · cites it directly · 3 of its ownK070711 Incircle BI-Polar RF Ablation SystemRfa Medical, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK070443 Intracept BI-Polar RF Probe, Model 04814Relievant Medsystems, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK083856 Intracept Flexible BI-Polar RF Probe and Curved Instrument Set…Relievant Medsystems, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK082954 Encage Bipolar RF ProbeTrod Medical SA · 2008
Most influential descendants
Showing 4 of 4 · See all- K070711Incircle BI-Polar RF Ablation SystemRfa Medical, Inc. · 2007 · cites it directly3descendants
- K070443Intracept BI-Polar RF Probe, Model 04814Relievant Medsystems, Inc. · 2007 · 2 generations on2descendants
- K083856Intracept Flexible BI-Polar RF Probe and Curved Instrument Set, Models: FG0018, FG0026Relievant Medsystems, Inc. · 2009 · 3 generations on0descendants
- K082954Encage Bipolar RF ProbeTrod Medical SA · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060419 | Concerto Bipolar Needle Electrode | Boston Scientific Corp | 2006 | — |
| +1 | K070711 | Incircle BI-Polar RF Ablation System | Rfa Medical, Inc. | 2007 | — |
| +2 | K070443 | Intracept BI-Polar RF Probe, Model 04814 | Relievant Medsystems, Inc. | 2007 | — |
| +3 | K083856 | Intracept Flexible BI-Polar RF Probe and Curved Instrument Set, Models… | Relievant Medsystems, Inc. | 2009 | — |
| +2 | K082954 | Encage Bipolar RF Probe | Trod Medical SA | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | ConcertoTM Bipolar Needle Electrode Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070711 | Incircle BI-Polar RF Ablation System | 2007 | 3 |
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?
- Of its descendants, K070711 (Rfa Medical, Inc., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
ConcertoTM Bipolar Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060419 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060419: Concerto Bipolar Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060419
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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