510(k) · Cleared
ClearedLeveen Standard Needle Electrode, Leveen Coaccess 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 Apr 17, 2014 as substantially equivalent to K992556 (Tissue Science Laboratories, Plc, 2000) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Apr 17, 2014
- Review
- 49 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992556 (2000). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK992556 PermacolTissue Science Laboratories, Plc · 2000
- This deviceK140495 Leveen Standard Needle Electrode, Leveen Coaccess Needle ElectrodeBoston Scientific Corp · 2014
- Descendant · cites it directly · 5 of its ownK150029 Habib EUS RFAEmcision, Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK181249 EUSRA RF ElectrodeStarmed Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK240932 HybridTherm SystemErbe Elektromedizin GmbH · 2024
- Descendant · 2 generations on · 1 of its ownK161305 Habib EUS RFAEmcision, Ltd. · 2016 · Recalled
- Descendant · 4 generations on · 0 of its ownK251108 Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K150029Habib EUS RFAEmcision, Ltd. · 2015 · cites it directly5descendants
- K181249EUSRA RF ElectrodeStarmed Co., Ltd. · 2018 · 2 generations on2descendants
- K240932HybridTherm SystemErbe Elektromedizin GmbH · 2024 · 3 generations on1descendant
- K161305Habib EUS RFAEmcision, Ltd. · 2016 · 2 generations on1descendant
- K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992556 | Permacol | Tissue Science Laboratories, Plc | 2000 | — |
| 0 (this device) | K140495 | Leveen Standard Needle Electrode, Leveen Coaccess Needle Electrode | Boston Scientific Corp | 2014 | — |
| +1 | K150029 | Habib EUS RFA | Emcision, Ltd. | 2015 | — |
| +2 | K181249 | EUSRA RF Electrode | Starmed Co., Ltd. | 2018 | — |
| +3 | K240932 | HybridTherm System | Erbe Elektromedizin GmbH | 2024 | — |
| +2 | K161305 | Habib EUS RFA | Emcision, Ltd. | 2016 | 2 |
| +4 | K251108 | Erbe ESU Model VIO® 3n with Accessories | Erbe Elektromedizin GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K992556 | PermacolSummary page 1…Plastic Surgery Classification: Class 11 3. Predicate Device: Boston Scientific Corporation's LeVeenTM Standard Needle Electrode System (K992556) Boston Scientific Corporation's LeVeenTM CoACCeSSTm Needle Electrode System (K0123 15) 4. Device Description:… | 2000 |
| * | K012315 | Leveen ElectrodeSummary page 1…Corporation's LeVeenTM Standard Needle Electrode System (K992556) Boston Scientific Corporation's LeVeenTM CoACCeSSTm Needle Electrode System (K0123 15) 4. Device Description: LeVeen Standard Needle Electrode System: The description of the proposed LeVeen Standard Nee… | 2001 |
| † | K113090 | Leveen Superslim Needle Electrode | 2012 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150029 | Habib EUS RFA | 2015 | 5 |
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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
The LeVeenTM Needle Electrode Family (which includes the LeVeenTM Standard Needle Electrode System and the LeVeenTM CoAccessTM Needle Electrode System) is intended to be used in conjunction with the RF3000 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/K140495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140495: Leveen Standard Needle Electrode, Leveen Coaccess Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140495
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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