510(k) · Cleared
ClearedBipolar Trigger-Flex Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellman Intl., Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 11, 2001 after a 188-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Apr 11, 2001
- Review
- 188 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 5 citing it directly.
- This deviceK003126 Bipolar Trigger-Flex ProbeEllman Intl., Inc. · 2001
- Descendant · cites it directly · 4 of its ownK130110 Meddusa Bipolar SystemElliquence, LLC · 2013
- Descendant · cites it directly · 3 of its ownK190336 Soniquence Bipolar ElectrodesSoniquence, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK202558 Ellusa Bipolar WandsEllusa, LLC · 2020
- Descendant · cites it directly · 1 of its ownK170377 TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF…Richard Wolf Medical Instruments Corporation · 2017
- Descendant · cites it directly · 1 of its ownK161378 joimax Electrosurgical InstrumentsJoimax GmbH · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K130110Meddusa Bipolar SystemElliquence, LLC · 2013 · cites it directly4descendants
- K190336Soniquence Bipolar ElectrodesSoniquence, LLC · 2019 · cites it directly3descendants
- K202558Ellusa Bipolar WandsEllusa, LLC · 2020 · 2 generations on1descendant
- K170377TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL…Richard Wolf Medical Instruments Corporation · 2017 · cites it directly1descendant
- K161378joimax Electrosurgical InstrumentsJoimax GmbH · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003126 | Bipolar Trigger-Flex Probe | Ellman Intl., Inc. | 2001 | — |
| +1 | K130110 | Meddusa Bipolar System | Elliquence, LLC | 2013 | — |
| +1 | K190336 | Soniquence Bipolar Electrodes | Soniquence, LLC | 2019 | — |
| +2 | K202558 | Ellusa Bipolar Wands | Ellusa, LLC | 2020 | — |
| +1 | K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO… | Richard Wolf Medical Instruments Corporation | 2017 | — |
| +1 | K161378 | joimax Electrosurgical Instruments | Joimax GmbH | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K130110 (Elliquence, LLC, 2013) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K003126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003126: Bipolar Trigger-Flex Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003126
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026