510(k) · Cleared
ClearedArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Livsmed, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 15, 2024 as substantially equivalent to K162941 (Covidien, 2016) and 1 other predicate after a 205-day review. Its family tree reaches back 10 generations to 1991. 1 later device descends from it.
- Decided
- Nov 15, 2024
- Review
- 205 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K911904 (1991). 48 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 6 generations between
- 3 generations backK170170 Valleylab FT10 Electrosurgical PlatformCovidien, LLC · 2017
- 2 generations backK172757 Valleylab FX8 Electrosurgical PlatformCovidien, LLC · 2017
- 1 generation backK181389 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy…Covidien · 2018
- This deviceK241138 ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel…Livsmed, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK250126 ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 9 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 8 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 7 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 6 generations backK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
- 5 generations backK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
- 4 generations backK151649 Valleylab FT10 Electrosurgical PlatformCovidien · 2015
- 3 generations backK170170 Valleylab FT10 Electrosurgical PlatformCovidien, LLC · 2017
- 2 generations backK172757 Valleylab FX8 Electrosurgical PlatformCovidien, LLC · 2017
- 1 generation backK181389 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy…Covidien · 2018
- This deviceK241138 ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel…Livsmed, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −9 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −8 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −7 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −6 | K100816 | PK Superpulse Sysem Generator Model 744000 | Gyrus Acmi, Inc. | 2010 | — |
| −5 | K110268 | Forcetriad Electrosurgical Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011 | — |
| −4 | K151649 | Valleylab FT10 Electrosurgical Platform | Covidien | 2015 | — |
| −3 | K170170 | Valleylab FT10 Electrosurgical Platform | Covidien, LLC | 2017 | — |
| −2 | K172757 | Valleylab FX8 Electrosurgical Platform | Covidien, LLC | 2017 | — |
| −1 | K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | Covidien | 2018 | — |
| 0 (this device) | K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing… | Livsmed, Inc. | 2024 | — |
| +1 | K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coatedSummary page 5…ion Name : Electrosurgical, Cutting & Coagulation & Accessories Regulation Number: 878.4400 Product Code : GEI Legally Marketed Predicate Devices Predicate device : K162941/Ligasure Blunt Tip, Sealer/Divider, Nano-coated/GEI Predicate device : K181389/Valleylab FT10 Energy Platform, Valleylab FX8 FX… | 2016 |
| * | K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformSummary page 5…er: 878.4400 Product Code : GEI Legally Marketed Predicate Devices Predicate device : K162941/Ligasure Blunt Tip, Sealer/Divider, Nano-coated/GEI Predicate device : K181389/Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform/GEI Device Description Summary ArtiSeal Vessel Sealing… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | 2025 | 0 |
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 33 years and passes through 8 companies; a new generation was cleared every 4.3 years on median.
- 9 of the 48 ancestors have a recall of any class.
- Of its descendants, K250126 (Livsmed, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162941.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
ArtiSeal Vessel Sealing System-ArtiSeal Instruments ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (sealing) and division (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in…
Read the full statement (136 words)
ArtiSeal Vessel Sealing System-ArtiSeal Instruments
ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (sealing) and division (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery.
ArtiSeal Vessel Sealing System-ArtiSeal Generator
The ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments, known as ArtiSeal Instruments. It provides radiofrequency (RF) energy to ligate vessels and tissue bundles. This energy platform automatically detects the connected instrument and immediately performs safety and diagnostic functions for the instrument. It is indicated for use in general surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241138: ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241138
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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