510(k) · Cleared
ClearedMeddusa Bipolar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elliquence, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 8, 2013 as substantially equivalent to K003126 (Ellman Intl., Inc., 2001) and 2 other predicates after a 265-day review. Its family tree reaches back 4 generations to 1996. 4 later devices descend from it.
- Decided
- Oct 8, 2013
- Review
- 265 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K954171 (1996). 9 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
- 3 generations backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
- 2 generations backK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
- 1 generation backK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
- This deviceK130110 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 · 3 generations on · 0 of its ownK222429 Ellusa Reusable Bipolar CableEllusa, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK211946 Soniquence Reusable Bipolar CableSoniquence, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K190336Soniquence Bipolar ElectrodesSoniquence, LLC · 2019 · cites it directly3descendants
- K202558Ellusa Bipolar WandsEllusa, LLC · 2020 · 2 generations on1descendant
- K222429Ellusa Reusable Bipolar CableEllusa, LLC · 2022 · 3 generations on0descendants
- K211946Soniquence Reusable Bipolar CableSoniquence, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954171 | Arco-MBC, Arco MC | Holl Meditronics, Inc. | 1996 | — |
| −3 | K993265 | Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 | Soring GmbH Medizintechnik | 1999 | — |
| −2 | K024059 | MBC Series | Soring GmbH Medizintechnik | 2003 | — |
| −1 | K052859 | Aquamantys Pump Generator System | Tissuelink Medical, Inc. | 2005 | 1 |
| 0 (this device) | K130110 | Meddusa Bipolar System | Elliquence, LLC | 2013 | — |
| +1 | K190336 | Soniquence Bipolar Electrodes | Soniquence, LLC | 2019 | — |
| +2 | K202558 | Ellusa Bipolar Wands | Ellusa, LLC | 2020 | — |
| +3 | K222429 | Ellusa Reusable Bipolar Cable | Ellusa, LLC | 2022 | — |
| +2 | K211946 | Soniquence Reusable Bipolar Cable | Soniquence, LLC | 2021 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K003126 | Bipolar Trigger-Flex ProbeSummary page 2…Page 2 of 3 Class Classification: Class 2. Product Code: GEl, 21 CFR 878.4400 Predicate Device * Bipolar Trigger-Flex Probe (51 0(k) K003126) * Aquamantys 2.3 Bipolar Sealer (510(k) K052859) * Disc-FX System (510(k) K052241) Description of the Device The Meddusa Bipol… | 2001 |
| * | K052859 | Aquamantys Pump Generator SystemSummary page 2…ss Classification: Class 2. Product Code: GEl, 21 CFR 878.4400 Predicate Device * Bipolar Trigger-Flex Probe (51 0(k) K003126) * Aquamantys 2.3 Bipolar Sealer (510(k) K052859) * Disc-FX System (510(k) K052241) Description of the Device The Meddusa Bipolar System is a disposable device manufacturer of… | 2005 |
| * | K052241 | Disc-FX SystemSummary page 2…ct Code: GEl, 21 CFR 878.4400 Predicate Device * Bipolar Trigger-Flex Probe (51 0(k) K003126) * Aquamantys 2.3 Bipolar Sealer (510(k) K052859) * Disc-FX System (510(k) K052241) Description of the Device The Meddusa Bipolar System is a disposable device manufacturer of medical grade Stainless Steel, ABS… | 2006 |
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 |
|---|---|---|---|
| K190336 | Soniquence Bipolar Electrodes | 2019 | 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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K190336 (Soniquence, LLC, 2019) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K003126.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Meddusa Bipolar System is a single-use product designed for and intended to be used exclusively with Surgi-MaxtV RF Generators (510(k) K1 00390). For optimal performance the Surgi-Max@ Plus generator (510(k) K100390) is recommended. The Meddusa Tm Bipolar System is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. The types of surgery intended are: General…
Read the full statement (93 words)
The Meddusa Bipolar System is a single-use product designed for and intended to be used exclusively with Surgi-MaxtV RF Generators (510(k) K1 00390). For optimal performance the Surgi-Max@ Plus generator (510(k) K100390) is recommended.
The Meddusa Tm Bipolar System is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Laryngeal coagulation, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130110: Meddusa Bipolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130110
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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