510(k) · Cleared
ClearedAquamantys Double Cone Bipolar Sealer Model: 23-310-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salient Surgical Technologies · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 5, 2011 as substantially equivalent to K014260 (Tissuelink Medical, Inc., 2002) and 1 other predicate after a 355-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.
- Decided
- Apr 5, 2011
- Review
- 355 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954171 (1996). 8 ancestors in all. 3 later devices descend from it, 2 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 deviceK101057 Aquamantys Double Cone Bipolar Sealer Model: 23-310-1Salient Surgical Technologies · 2011
- Descendant · cites it directly · 1 of its ownK120537 AQUAMANTYS3 9.5 XL Bipolar SealerMedtronic, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK211203 Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC · 2022
- Descendant · cites it directly · 0 of its ownK123201 Aquamantys Endo DBS 8.7 Dissecting Bipolar SealerMedtronic Advanced Energy, LLC · 2013
Most influential descendants
Showing 3 of 3 · See all- K120537AQUAMANTYS3 9.5 XL Bipolar SealerMedtronic, Inc. · 2012 · cites it directly1descendant
- K211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC · 2022 · 2 generations on0descendants
- K123201Aquamantys Endo DBS 8.7 Dissecting Bipolar SealerMedtronic Advanced Energy, LLC · 2013 · cites it directly0descendants
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) | K101057 | Aquamantys Double Cone Bipolar Sealer Model: 23-310-1 | Salient Surgical Technologies | 2011 | — |
| +1 | K120537 | AQUAMANTYS3 9.5 XL Bipolar Sealer | Medtronic, Inc. | 2012 | — |
| +2 | K211203 | Green OR Reprocessed Aquamantys Bipolar Sealer | Green Or, LLC | 2022 | — |
| +1 | K123201 | Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer | Medtronic Advanced Energy, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K014260 | Tissuelink Solid Cylinder Monopolar DeviceSummary page 1…ss: Class 11 4. Legally Marketed Equivalent Device: TissueL-ink Solid Cylinder Monopolar Device 510O(k) K0 14260 Aquamantys Pump Generator System… | 2002 |
| * | K052859 | Aquamantys Pump Generator SystemSummary page 1…p Generator System (including AQM Bipolar Sealers 2.3 and 6.0) 5 10O(k) K052859 I of 3 5. Performan… | 2005 |
What descends from it? (3)
2 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 15 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K120537 (Medtronic, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K014260.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Double Cone Bipolar Sealer is a single use, sterile, bipolar device, intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, open abdominal, orthopaedic, and thoracic 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/K101057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101057: Aquamantys Double Cone Bipolar Sealer Model: 23-310-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101057
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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