510(k) Report

510(k) · Cleared

Cleared

Ligasure 5MM Blunt Tip Laparoscopic Sealer/Divider

K130744510(k) SpecialCleared Apr 5, 201317-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 Apr 5, 2013 as substantially equivalent to K092879 (Valleylab, 2009) after a 17-day review. Its family tree reaches back 4 generations to 1994. 42 later devices descend from it.

Decided
Apr 5, 2013
Review
17 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K932293 (1994). 10 ancestors in all. 42 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1996: 1 other ancestor1995: 4 other ancestors2015: 3 descendants cleared2014: 1 descendant cleared2016: 6 descendants cleared2018: 4 descendants cleared2017: 4 descendants cleared2021: 6 descendants cleared2023: 6 descendants cleared2024: 2 descendants cleared2022: 3 descendants cleared2026: 4 descendants cleared2020: 2 descendants cleared2025: 1 descendant clearedK932293 · Cabot Medical Bipolar Cutting Forceps · Cabot Medical Corp. · 1994 · recalledK981916 · Ligasure Vessel Sealing System · Valleylab, Inc. · 1998K031011 · Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 · Valleylab, Inc. · 2003 · recalledK092879 · Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider · Valleylab · 2009 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 5 other ancestors 1 generation forward: 4 descendants2 generations forward: 12 descendants3 generations forward: 14 descendants4 generations forward: 8 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K092879 · Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider · Valleylab · 2009 · recalledK031011 · Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 · Valleylab, Inc. · 2003 · recalledK981916 · Ligasure Vessel Sealing System · Valleylab, Inc. · 1998K932293 · Cabot Medical Bipolar Cutting Forceps · Cabot Medical Corp. · 1994 · recalled0+5
  1. Root · 4 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
  2. 3 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
  3. 2 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
  4. 1 generation backK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · Recalled
  5. This deviceK130744 Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerCovidien · 2013
  6. Descendant · cites it directly · 40 of its ownK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
  7. Descendant · 2 generations on · 14 of its ownK152286 LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015
  8. Descendant · 2 generations on · 11 of its ownK170869 LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017
  9. Descendant · cites it directly · 6 of its ownK142929 Ligasure Blunt Tip Sealer/DividerCovidien · 2015
  10. Descendant · 3 generations on · 5 of its ownK173281 LigaSure Exact Dissector, Nano-coatedCovidien · 2018

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2014: 12015: 32016: 62017: 42018: 42020: 22021: 62022: 32023: 62024: 22025: 12026: 4
2014high 6 (2016) · low 0 (2019)2026

Most influential descendants

Showing 5 of 42 · 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
  • K142929Ligasure Blunt Tip Sealer/DividerCovidien · 2015 · cites it directly6descendants
  • K173281LigaSure Exact Dissector, Nano-coatedCovidien · 2018 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K932293Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp.19943
−3K981916Ligasure Vessel Sealing SystemValleylab, Inc.1998—
−2K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc.20032
−1K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab20091
0 (this device)K130744Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerCovidien2013—
+1K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider…Covidien2014—
+2K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien2015—
+2K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien2017—
+1K142929Ligasure Blunt Tip Sealer/DividerCovidien2015—
+3K173281LigaSure Exact Dissector, Nano-coatedCovidien2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199540
199610
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201530
201660
201740
201840
202020
202160
202230
202360
202420
202510
202640
FIG. 1 — Lineage of K130744, 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
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What was it cleared against? (1)

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
*K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider
Summary page 1
…Laparoscopic Sealer/Divider Device Common Name: Bipolar Electrosurgical Instrument Catalog Number: LF 1537 5 10O(k) Number: K092879 (cleared 10/ 16/2009) Manufacturer: Covidien Device Description The LigaSureTM 5 mm Blunt Tip Laparoscopic Sea…
Valleylab20091

Also cleared against K092879: 4 other devices →

What descends from it? (42)

See all 42

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

NumberDeviceApplicantDecidedDescendants
K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien201440
K142929Ligasure Blunt Tip Sealer/DividerCovidien20156
K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien20164
K143260Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/DividerSterilmed, Inc.20150

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 4 companies; a new generation was cleared every 4.8 years on median.
  • 4 of the 10 ancestors have a recall of any class.
  • Of its descendants, K141153 (Covidien, 2014) has gone furthest, with 40 descendants of its own.
  • 4 other devices also cite its predicate K092879.

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. 2013, 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 LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within…

Read the full statement (162 words)

The LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5 mm Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K130744: Ligasure 5MM Blunt Tip Laparoscopic Sealer/Divider.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130744

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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