510(k) · Cleared
ClearedLigasure Impact Curved, Large Jaw, Open Sealer / Divider
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly Valleylab, A Division of Tyco H · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 30, 2013 as substantially equivalent to K112033 (Ethicon Endo-Sugery, LLC, 2011) and 2 other predicates after an 83-day review. Its family tree reaches back 4 generations to 1994. 56 later devices descend from it.
- Decided
- Jan 30, 2013
- Review
- 83 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K932293 (1994). 13 ancestors in all. 56 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 3 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 2 generations backK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
- 1 generation backK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
- This deviceK123444 Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2013
- Descendant · cites it directly · 40 of its ownK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- Descendant · 2 generations on · 14 of its ownK152286 LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015
- Descendant · 2 generations on · 11 of its ownK170869 LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017
- Descendant · cites it directly · 6 of its ownK160554 Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC · 2016
- Descendant · 2 generations on · 6 of its ownK142929 Ligasure Blunt Tip Sealer/DividerCovidien · 2015
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien · 2014 · cites it directly40descendants
- K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015 · 2 generations on14descendants
- K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017 · 2 generations on11descendants
- K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC · 2016 · cites it directly6descendants
- K142929Ligasure Blunt Tip Sealer/DividerCovidien · 2015 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −3 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −2 | K051644 | Valleylab Forcetriad Electrosurgical Generator | Valleylab | 2005 | — |
| −1 | K070162 | Forcetriad Electrosurgical Generator; Ligasure Instruments | Valleylab,A Division of Tyco Healthcare Group LP | 2007 | — |
| 0 (this device) | K123444 | Ligasure Impact Curved, Large Jaw, Open Sealer / Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| +1 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| +2 | K152286 | LigaSure Curved, Small Jaw, Open Sealer/Divider | Covidien | 2015 | — |
| +2 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | Covidien | 2017 | — |
| +1 | K160554 | Enseal X1 Large Jaw Tissue Sealer | Ethicon Endo-Surgery, LLC | 2016 | — |
| +2 | K142929 | Ligasure Blunt Tip Sealer/Divider | Covidien | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 10 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K112033 | Enseal G2 Tissus SealersSummary page 1…Device Common Name: Bipolar electrosurgical instrument Trade Name: Enseal G2 Tissue Sealer Catalog Number: NSEALX,22L 51 0(k) Number: 1112033 Manufacturer: Ethicon Endo-Surgery, LLC Device Common Name: Bipolar electrosurgical instrument Tra… | 2011 |
| * | K010013 | Ligasure Laparoscopic Sealer Divider Model LS1100Summary page 1…on Name: Bipolar electrosurgical instrument Trade Name: LigaSure Atlas, Tissue Fusion Open Instrument Catalog Number: LS1020 610(k) Number: K010013 Manufacturer: Covidien Device Common Name: ForceTriad Electrosurgical Generator; LigaSure Instruments… | 2001 |
| * | K070162 | Forcetriad Electrosurgical Generator; Ligasure InstrumentsSummary page 1…r: Covidien Device Common Name: ForceTriad Electrosurgical Generator; LigaSure Instruments Trade Name: ForceTriad generator 510(k) Number: K070162 Manufacturer: Covidien Device Description The LigaSure Impact m , Curved, -Large Jaw, Open Sealer/Divider (LF4318) i… | 2007 |
What descends from it? (56)
See all 567 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw… | 2014 | 40 |
| K160554 | Enseal X1 Large Jaw Tissue Sealer | 2016 | 6 |
| K162676 | Voyant Open Fusion Device | 2016 | 3 |
| K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | 2016 | 3 |
| K143517 | Voyant Open Sealer-Divider Device | 2015 | 1 |
| K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider | 2016 | 0 |
| K150538 | Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider | 2015 | 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 19 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K141153 (Covidien, 2014) has gone furthest, with 40 descendants of its own.
- 6 other devices also cite its predicate K112033.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ImpactT" Curved, Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LigaSure Impact LF4318 is intended to be used with the ForceTriadM energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. The indications for use include open procedures (general, urologic, vascular…
Read the full statement (141 words)
The LigaSure ImpactT" Curved, Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LigaSure Impact LF4318 is intended to be used with the ForceTriadM energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Impact LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7mm and tissue bundles.
The LigaSure TM 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/K123444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123444: Ligasure Impact Curved, Large Jaw, Open Sealer / Divider.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123444
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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