510(k) · Cleared
ClearedGreen OR Reprocessed Aquamantys Bipolar Sealer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Green Or, LLC · NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Cleared on Apr 7, 2022 as substantially equivalent to K132974 (Medtronic Advanced Energy, LLC, 2013) and 2 other predicates after a 350-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Apr 7, 2022
- Review
- 350 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K954171 (1996). 17 ancestors in all, the oldest K813071 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
- 6 generations backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
- 5 generations backK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
- 4 generations backK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
- 3 generations backK063639 Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
- 2 generations backK111732 Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011
- 1 generation backK132974 Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini…Medtronic Advanced Energy, LLC · 2013
- This deviceK211203 Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954171 | Arco-MBC, Arco MC | Holl Meditronics, Inc. | 1996 | — |
| −6 | K993265 | Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 | Soring GmbH Medizintechnik | 1999 | — |
| −5 | K024059 | MBC Series | Soring GmbH Medizintechnik | 2003 | — |
| −4 | K052859 | Aquamantys Pump Generator System | Tissuelink Medical, Inc. | 2005 | 1 |
| −3 | K063639 | Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1 | Tissuelink Medical, Inc. | 2007 | — |
| −2 | K111732 | Aquamantys SBS 5.0 Sheated Biopolar Sealer | Salient Surgical Technologies, Inc. | 2011 | — |
| −1 | K132974 | Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4… | Medtronic Advanced Energy, LLC | 2013 | — |
| 0 (this device) | K211203 | Green OR Reprocessed Aquamantys Bipolar Sealer | Green Or, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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 NUJ? 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 NUJ device
- #1 K220411 Reprocessed LigaSure Curved, Small Jaw, Open…score 8.4 · 8 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 |
|---|---|---|---|
| * | K132974 | Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein…Summary page 5…ories Regulation: 21 CFR 878.4400 Device Class: Class Il Product Code: NUJ MPredlcate Device Name 510(k) anufacturer EE\E%EATE Medtronic Aquamantys 2.3 Bipolar Sealer K132974 Medtronic Aquamantys 9.5 XL Bipolar Sealer K120537 Medtronic Aquamantys 6.0 Bipolar Sealer K111285 EE\FIFCREENCE No reference dev… | 2013 |
| * | K120537 | AQUAMANTYS3 9.5 XL Bipolar SealerSummary page 5…ass Il Product Code: NUJ MPredlcate Device Name 510(k) anufacturer EE\E%EATE Medtronic Aquamantys 2.3 Bipolar Sealer K132974 Medtronic Aquamantys 9.5 XL Bipolar Sealer K120537 Medtronic Aquamantys 6.0 Bipolar Sealer K111285 EE\FIFCREENCE No reference devices were used in this submission. The Reprocessed… | 2012 |
| * | K111285 | Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with CuttingSummary page 5…e 510(k) anufacturer EE\E%EATE Medtronic Aquamantys 2.3 Bipolar Sealer K132974 Medtronic Aquamantys 9.5 XL Bipolar Sealer K120537 Medtronic Aquamantys 6.0 Bipolar Sealer K111285 EE\FIFCREENCE No reference devices were used in this submission. The Reprocessed Aquamantys Bipolar Sealer is a sterile, single-u… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 5 of the 17 ancestors have a recall of any class.
- 3 other devices also cite its predicate K132974.
How does its category compare?
All NUJ devicesNUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NUJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NUJ
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUJ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUJ
38in 2025
MAUDE reports naming product code NUJ, 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 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 2 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 39 |
| 2013 | 2 | — | 0 | 161 |
| 2014 | 1 | — | 0 | 74 |
| 2015 | 2 | — | 0 | 25 |
| 2016 | 5 | 155 | 0 | 52 |
| 2017 | 3 | 49 | 0 | 51 |
| 2018 | 7 | 88 | 0 | 14 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 59 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 2 | — | 0 | 31 |
| 2023 | 1 | — | 3 | 27 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 0 | — | 11 | 38 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). The Green OR Reprocessed Aquamantys 2.3…
Read the full statement (126 words)
The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery.
The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery.
The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is intended for, but not limited to open abdominal, orthopaedic, and thoracic surgery.
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/K211203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211203: Green OR Reprocessed Aquamantys Bipolar Sealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211203
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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