510(k) · Cleared
Recalled · Class II · 2021Ligasure Blunt Tip, Sealer/Divider, Nano-coated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 14, 2016 as substantially equivalent to K130744 (Covidien, 2013) and 2 other predicates after a 24-day review. Its family tree reaches back 8 generations to 1994. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 14, 2016
- Review
- 24 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K932293 (1994). 23 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 7 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 6 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 5 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 4 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 3 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- 2 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 1 generation backK142929 Ligasure Blunt Tip Sealer/DividerCovidien · 2015
- This deviceK162941 Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien · 2016
- Descendant · cites it directly · 1 of its ownK241138 ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel…Livsmed, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK223158 LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK260636 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without…Stryker Sustainability Solutions · 2026
- Descendant · 2 generations on · 0 of its ownK250126 ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc. · 2024 · cites it directly1descendant
- K223158LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC · 2023 · cites it directly1descendant
- K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions · 2026 · 2 generations on0descendants
- K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −7 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −6 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −5 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −4 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −3 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| −2 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| −1 | K142929 | Ligasure Blunt Tip Sealer/Divider | Covidien | 2015 | — |
| 0 (this device) | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | Covidien | 2016 | — |
| +1 | K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing… | Livsmed, Inc. | 2024 | — |
| +1 | K223158 | LigaSure™ XP Maryland Jaw Sealer/Divider | Covidien, LLC | 2023 | — |
| +2 | K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | 2026 | — |
| +2 | K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K130744 | Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerSummary page 4…vice Trade Name: LigaSure™ Blunt Tip Sealer/Divider (LF1623, LF1637, LF1644) Common Name: Bipolar Vessel Sealing Device 510(k) Number: K130744 (cleared 04/05/2013), K141153 (cleared 8/14/2014), K142929 (cleared 01/27/2015) Manufacturer:… | 2013 |
| * | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Summary page 4…LigaSure™ Blunt Tip Sealer/Divider (LF1623, LF1637, LF1644) Common Name: Bipolar Vessel Sealing Device 510(k) Number: K130744 (cleared 04/05/2013), K141153 (cleared 8/14/2014), K142929 (cleared 01/27/2015) Manufacturer: Covidien Reference Devices Tr… | 2014 |
| * | K142929 | Ligasure Blunt Tip Sealer/DividerSummary page 4…vider (LF1623, LF1637, LF1644) Common Name: Bipolar Vessel Sealing Device 510(k) Number: K130744 (cleared 04/05/2013), K141153 (cleared 8/14/2014), K142929 (cleared 01/27/2015) Manufacturer: Covidien Reference Devices Trade Name: LigaSu… | 2015 |
| † | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | 2016 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2021 | Class II | Z-0495-2022 | Device Design | Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 23 ancestors have a recall of any class.
- Of its descendants, K241138 (Livsmed, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K130744.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may…
Read the full statement (109 words)
The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162941: Ligasure Blunt Tip, Sealer/Divider, Nano-coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162941
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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