510(k) · Cleared
ClearedLigaSure Impact Curved, Large Jaw, Open 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 Sep 15, 2016 as substantially equivalent to K123444 (Covidien, Formerly Valleylab, A Division of Tyco H, 2013) and 1 other predicate after a 52-day review. Its family tree reaches back 7 generations to 1994. 3 later devices descend from it.
- Decided
- Sep 15, 2016
- Review
- 52 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K932293 (1994). 22 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 6 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 5 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 4 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 3 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 2 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- 1 generation backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- This deviceK162047 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedCovidien · 2016
- Descendant · cites it directly · 1 of its ownK181085 LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing…Covidien · 2018
- Descendant · cites it directly · 0 of its ownK252487 POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action…Gyrus Acmi, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK231732 CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation · 2023
Most influential descendants
Showing 3 of 3 · See all- K181085LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2018 · cites it directly1descendant
- K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Gyrus Acmi, Inc. · 2026 · cites it directly0descendants
- K231732CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −6 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −5 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −4 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −3 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −2 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| −1 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| 0 (this device) | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | Covidien | 2016 | — |
| +1 | K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | Covidien | 2018 | — |
| +1 | K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | 2026 | — |
| +2 | K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland | Conmed Corporation | 2023 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K123444 | Ligasure Impact Curved, Large Jaw, Open Sealer / DividerSummary page 4…LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider Catalog Number: LF4318 Common Name: Bipolar Vessel Sealing Device 510(k) Number: K123444 (cleared 1/30/2013), K141153 (cleared 8/14/2014) Manufacturer: Covidien Recalls: This device has not b… | 2013 |
| * | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Summary page 4…rge Jaw, Open Sealer/Divider Catalog Number: LF4318 Common Name: Bipolar Vessel Sealing Device 510(k) Number: K123444 (cleared 1/30/2013), K141153 (cleared 8/14/2014) Manufacturer: Covidien Recalls: This device has not been subject to a design-relat… | 2014 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 22 ancestors have a recall of any class.
- Of its descendants, K181085 (Covidien, 2018) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K123444.
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 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, veins, pulmonary arteries, pulmonary 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.…
Read the full statement (110 words)
The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in 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, veins, pulmonary arteries, pulmonary 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/K162047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162047: LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162047
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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