510(k) · Cleared
ClearedLigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, 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 Jun 21, 2018 as substantially equivalent to K162047 (Covidien, 2016) and 3 other predicates after a 57-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it.
- Decided
- Jun 21, 2018
- Review
- 57 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K932293 (1994). 24 ancestors in all. 1 later device descends from it, 1 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 backK162047 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedCovidien · 2016
- This deviceK181085 LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing…Covidien · 2018
- Descendant · cites it directly · 0 of its ownK231732 CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K231732CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation · 2023 · cites it directly0descendants
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 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | Covidien | 2016 | — |
| 0 (this device) | K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | Covidien | 2018 | — |
| +1 | 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 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedSummary page 4…r, Nano- coated (LF4418) Common Name: Bipolar Vessel Sealing Device Catalog Number: LF4418 510(k) Number: K162047 (cleared 9/15/16) Manufacturer: Covidien Recalls: This device has not been subject to a design-rel… | 2016 |
| * | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Summary page 4…vider One-step Sealing, Nano-coated Common Name: Bipolar Vessel Sealing Device Catalog Number: LF1923, LF1937, LF1944 510(k) Number: K133338 (cleared 12/20/2013), K141153 (cleared 8/14/2014), K170869 (cleared 04/21/2017) Manufacturer:… | 2013 |
| * | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Summary page 4…oated Common Name: Bipolar Vessel Sealing Device Catalog Number: LF1923, LF1937, LF1944 510(k) Number: K133338 (cleared 12/20/2013), K141153 (cleared 8/14/2014), K170869 (cleared 04/21/2017) Manufacturer: Covidien Recalls:… | 2014 |
| * | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedSummary page 4…Bipolar Vessel Sealing Device Catalog Number: LF1923, LF1937, LF1944 510(k) Number: K133338 (cleared 12/20/2013), K141153 (cleared 8/14/2014), K170869 (cleared 04/21/2017) Manufacturer: Covidien Recalls: This device has no… | 2017 |
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 |
|---|---|---|---|
| K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland | 2023 | 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 24 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 24 ancestors have a recall of any class.
- Of its descendants, K231732 (Conmed Corporation, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162047.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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, 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…
Read the full statement (113 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, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181085 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181085: LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181085
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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