510(k) · Cleared
ClearedAquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0 Sheathed Bipolar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Advanced Energy, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 3, 2013 as substantially equivalent to K896541 (Valley Forge Scientific Corp., 1990) and 3 other predicates after a 71-day review. Its family tree reaches back 6 generations to 1996. 4 later devices descend from it.
- Decided
- Dec 3, 2013
- Review
- 71 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K954171 (1996). 10 ancestors in all, the oldest K896541 (1990). 4 later devices descend from it, 4 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 backK063639 Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
- 1 generation backK111732 Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011
- This deviceK132974 Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini…Medtronic Advanced Energy, LLC · 2013
- Descendant · cites it directly · 1 of its ownK143175 AEx Generator; PlasmaBlade TMedtronic Advanced Energy · 2014
- Descendant · cites it directly · 0 of its ownK211203 Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC · 2022
- Descendant · cites it directly · 0 of its ownK170381 Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer…Medtronic Advanced Energy · 2017
- Descendant · cites it directly · 0 of its ownK170610 PlasmaBlade TMedtronic Advanced Energy · 2017
Most influential descendants
Showing 4 of 4 · See all- K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy · 2014 · cites it directly1descendant
- K211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC · 2022 · cites it directly0descendants
- K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex MiniMedtronic Advanced Energy · 2017 · cites it directly0descendants
- K170610PlasmaBlade TMedtronic Advanced Energy · 2017 · 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 | K063639 | Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1 | Tissuelink Medical, Inc. | 2007 | — |
| −1 | K111732 | Aquamantys SBS 5.0 Sheated Biopolar Sealer | Salient Surgical Technologies, Inc. | 2011 | — |
| 0 (this device) | K132974 | Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4… | Medtronic Advanced Energy, LLC | 2013 | — |
| +1 | K143175 | AEx Generator; PlasmaBlade T | Medtronic Advanced Energy | 2014 | — |
| +1 | K211203 | Green OR Reprocessed Aquamantys Bipolar Sealer | Green Or, LLC | 2022 | — |
| +1 | K170381 | Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini | Medtronic Advanced Energy | 2017 | — |
| +1 | K170610 | PlasmaBlade T | Medtronic Advanced Energy | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K896541 | Malis Bipolar Electrosurgical System CMC-IiiSummary page 1…sification Name: Electrosurgical culling and coagulation device and accessories Predicate Device: (Codman Irrigated Bipolar Forceps) K896541 Malis Bipolar Electrosurgical System CMC Ill (Medtronic Advanced Energy Aquamnantys Bipolar Sealers)… | 1990 |
| * | K052859 | Aquamantys Pump Generator SystemSummary page 1…K896541 Malis Bipolar Electrosurgical System CMC Ill (Medtronic Advanced Energy Aquamnantys Bipolar Sealers) K(052859 Aquamantys 2.3 Bipolar Sealer K(063639 Aquamantys EVS 4.0 Epidural Vein Sealer… | 2005 |
| * | K063639 | Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Summary page 1…alers) K(052859 Aquamantys 2.3 Bipolar Sealer K(063639 Aquamantys EVS 4.0 Epidural Vein Sealer K063639 Aquamantys Mini EVS 3.4 Epidural Vein Sealer K1 11732 Aquamantys SBS 5.0 Sheathed Bipolar Sealer Device… | 2007 |
| * | K111732 | Aquamantys SBS 5.0 Sheated Biopolar SealerSummary page 1…K(063639 Aquamantys EVS 4.0 Epidural Vein Sealer K063639 Aquamantys Mini EVS 3.4 Epidural Vein Sealer K1 11732 Aquamantys SBS 5.0 Sheathed Bipolar Sealer Device Description: The Aquamantys Bipolar Sealer is a sterile, single-use bipol… | 2011 |
| * | — | Codman Irrigated Bipolar Forceps Named without a submission number |
What descends from it? (4)
4 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?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K143175 (Medtronic Advanced Energy, 2014) has gone furthest, with 1 descendant 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. 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 Aquamantys 2.3 Bipolar Sealer is a sterile, single-use, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RIF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthiopaedic, neurosurgical, spine, thoracic, and open abdominal surgery. The device is not Intended for contraceptive tubal…
Read the full statement (232 words)
The Aquamantys 2.3 Bipolar Sealer is a sterile, single-use, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RIF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthiopaedic, neurosurgical, spine, thoracic, and open abdominal surgery. The device is not Intended for contraceptive tubal coagulation (permanent female sterilization).
The Aquamantys Epidural Vein Sealer is a sterile, singte-use bipolar electrosurgical device intended to be used in conijunction with the Aquamantys Pump Generator for delivery of RIF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It Is intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not Intended for contraceptive tubal coagulation (permanent female sterilization).
The Aquamantys 585 5.0 Sheathed Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used In conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative shte. It is Intended for, but not limited to orthopaedic. neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device Is not intended for contraceptive tubal coagulation (permanent female sterilization).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132974 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132974: Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0 Sheathed Bipolar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132974
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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