510(k) Report

510(k) · Cleared

Cleared

Ligasure Blunt Tip Sealer/Divider

K142929510(k) TraditionalCleared Jan 27, 2015110-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Covidien · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jan 27, 2015 as substantially equivalent to K130744 (Covidien, 2013) and 1 other predicate after a 110-day review. Its family tree reaches back 7 generations to 1994. 6 later devices descend from it.

Decided
Jan 27, 2015
Review
110 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. 6 later devices descend from it, 2 citing it directly.

  1. Root · 7 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
  2. 6 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
  3. 5 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
  4. 4 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
  5. 3 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
  6. 2 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
  7. 1 generation backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
  8. This deviceK142929 Ligasure Blunt Tip Sealer/DividerCovidien · 2015
  9. Descendant · cites it directly · 4 of its ownK162941 Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien · 2016 · Recalled
  10. Descendant · 2 generations on · 1 of its ownK241138 ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel…Livsmed, Inc. · 2024
  11. Descendant · 2 generations on · 1 of its ownK223158 LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC · 2023
  12. Descendant · 3 generations on · 0 of its ownK260636 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without…Stryker Sustainability Solutions · 2026
  13. Descendant · 3 generations on · 0 of its ownK250126 ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2016: 22023: 12024: 12025: 12026: 1
2016high 2 (2016) · low 0 (2017)2026

Most influential descendants

Showing 5 of 6 · See all
  • K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien · 2016 · cites it directly4descendants
  • K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc. · 2024 · 2 generations on1descendant
  • K223158LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC · 2023 · 2 generations on1descendant
  • K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions · 2026 · 3 generations on0descendants
  • K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K932293Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp.19943
−6K981916Ligasure Vessel Sealing SystemValleylab, Inc.1998—
−5K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc.20032
−4K102470Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab,2011—
−3K113572Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H2012—
−2K133338Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H2013—
−1K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider…Covidien2014—
0 (this device)K142929Ligasure Blunt Tip Sealer/DividerCovidien2015—
+1K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien20161
+2K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.2024—
+2K223158LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC2023—
+3K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions2026—
+3K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199540
199610
200120
200510
200730
200910
201110
201320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
202310
202410
202510
202610
FIG. 1 — Lineage of K142929, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K130744Ligasure 5MM Blunt Tip Laparoscopic Sealer/Divider
Summary page 4
…LigaSure™ Blunt Tip Laparoscopic Sealer/Divider Common Name: Bipolar Vessel Sealing Device Catalog Number: LF1637 510(k) Number: K130744 (cleared 4/17/2013), K141153 (cleared 8/14/2014) Manufacturer: Covidien Recalls: This device has not b…
Covidien2013—
*K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…
Summary page 4
…Laparoscopic Sealer/Divider Common Name: Bipolar Vessel Sealing Device Catalog Number: LF1637 510(k) Number: K130744 (cleared 4/17/2013), K141153 (cleared 8/14/2014) Manufacturer: Covidien Recalls: This device has not been subject to a design-relat…
Covidien2014—

Also cleared against K130744: 3 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien20164
K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/DividerSurgical Instrument Service and Savings, Inc.20160

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 21 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 6 of the 22 ancestors have a recall of any class.
  • Of its descendants, K162941 (Covidien, 2016) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K130744.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

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 specialities 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 specialities 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.

Cite this page

510(k) Report. “K142929: Ligasure Blunt Tip 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/K142929

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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