510(k) · Cleared
ClearedPOWERSEAL Sealer and Divider
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 25, 2023 as substantially equivalent to K212643 (Olympus Surgical Technologies America, 2021) and 1 other predicate after a 170-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Oct 25, 2023
- Review
- 170 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K932293 (1994). 38 ancestors in all, the oldest K911904 (1991). No later device cites it as a predicate yet.
- Root · 9 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 5 generations between
- 3 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 2 generations backK203682 Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved…Olympus Winter & Ibe GmbH · 2021
- 1 generation backK212643 POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America · 2021 · Recalled
- This deviceK231327 POWERSEAL Sealer and DividerGyrus Acmi, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 8 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 7 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 6 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 5 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 4 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- 3 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 2 generations backK203682 Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved…Olympus Winter & Ibe GmbH · 2021
- 1 generation backK212643 POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America · 2021 · Recalled
- This deviceK231327 POWERSEAL Sealer and DividerGyrus Acmi, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −8 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −7 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −6 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −5 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −4 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| −3 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| −2 | K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer… | Olympus Winter & Ibe GmbH | 2021 | — |
| −1 | K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action | Olympus Surgical Technologies America | 2021 | 7 |
| 0 (this device) | K231327 | POWERSEAL Sealer and Divider | Gyrus Acmi, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double ActionSummary page 6…ider Traditional 510(k) Notification Gyrus ACMI, Inc. Predicate Device POWERSEAL K212643, K203682 The predicate K212643 demonstrated POWERSEAL compatibility with the ESG-410 electrosurgical generator, with no other de… | 2021 |
| * | K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Summary page 6…Traditional 510(k) Notification Gyrus ACMI, Inc. Predicate Device POWERSEAL K212643, K203682 The predicate K212643 demonstrated POWERSEAL compatibility with the ESG-410 electrosurgical generator, with no other device chan… | 2021 |
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 29 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 9 of the 38 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such…
Read the full statement (124 words)
The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.
The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231327: POWERSEAL Sealer and Divider.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231327
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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