510(k) · Cleared
ClearedEllusa Bipolar Wands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellusa, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 2, 2020 as substantially equivalent to K190336 (Soniquence, LLC, 2019) after a 59-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Nov 2, 2020
- Review
- 59 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954171 (1996). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
- 5 generations backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
- 4 generations backK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
- 3 generations backK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
- 2 generations backK130110 Meddusa Bipolar SystemElliquence, LLC · 2013
- 1 generation backK190336 Soniquence Bipolar ElectrodesSoniquence, LLC · 2019
- This deviceK202558 Ellusa Bipolar WandsEllusa, LLC · 2020
- Descendant · cites it directly · 0 of its ownK222429 Ellusa Reusable Bipolar CableEllusa, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K222429Ellusa Reusable Bipolar CableEllusa, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954171 | Arco-MBC, Arco MC | Holl Meditronics, Inc. | 1996 | — |
| −5 | K993265 | Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 | Soring GmbH Medizintechnik | 1999 | — |
| −4 | K024059 | MBC Series | Soring GmbH Medizintechnik | 2003 | — |
| −3 | K052859 | Aquamantys Pump Generator System | Tissuelink Medical, Inc. | 2005 | 1 |
| −2 | K130110 | Meddusa Bipolar System | Elliquence, LLC | 2013 | — |
| −1 | K190336 | Soniquence Bipolar Electrodes | Soniquence, LLC | 2019 | — |
| 0 (this device) | K202558 | Ellusa Bipolar Wands | Ellusa, LLC | 2020 | — |
| +1 | K222429 | Ellusa Reusable Bipolar Cable | Ellusa, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K190336 | Soniquence Bipolar ElectrodesSummary page 5…6-1 K202558 Ellusa, LLC Predicate Devices (807.92(a)(3)) Soniquence Bipolar Electrodes (K190336) Use of Guidance Documents The content provided within this 510k follows the FDA guidance document “Premarket Notification (510(… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222429 | Ellusa Reusable Bipolar Cable | 2022 | 0 |
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 24 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K222429 (Ellusa, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K190336.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Ellusa Bipolar Wands are intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202558: Ellusa Bipolar Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202558
Report an extraction error
Are you the manufacturer?
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