510(k) Report

510(k) · Cleared

Cleared

Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure Generator

K010010510(k) TraditionalCleared Apr 2, 200190-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

Valleylab, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 2, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 91 later devices descend from it.

Decided
Apr 2, 2001
Review
90 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

91 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 3 descendants cleared2003: 1 descendant cleared2012: 2 descendants cleared2004: 1 descendant cleared2006: 1 descendant cleared2008: 4 descendants cleared2016: 11 descendants cleared2015: 6 descendants cleared2013: 3 descendants cleared2014: 4 descendants cleared2020: 5 descendants cleared2009: 1 descendant cleared2021: 10 descendants cleared2018: 8 descendants cleared2017: 6 descendants cleared2022: 3 descendants cleared2010: 1 descendant cleared2019: 2 descendants cleared2023: 10 descendants cleared2026: 5 descendants cleared2024: 2 descendants cleared2025: 2 descendants cleared200020052010201520202025
  1. This deviceK010010 Valleylab Ligasure Precise Instrument Vessel Sealing System-Model #…Valleylab, Inc. · 2001
  2. Descendant · cites it directly · 64 of its ownK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
  3. Descendant · cites it directly · 62 of its ownK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
  4. Descendant · 2 generations on · 43 of its ownK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
  5. Descendant · 2 generations on · 40 of its ownK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
  6. Descendant · 2 generations on · 14 of its ownK152286 LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015

Showing 5 of 91 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12006: 12008: 42009: 12010: 12011: 32012: 22013: 32014: 42015: 62016: 112017: 62018: 82019: 22020: 52021: 102022: 32023: 102024: 22025: 22026: 5
2003high 11 (2016) · low 0 (2005)2026

Most influential descendants

Showing 5 of 91 · See all
  • K102470Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011 · cites it directly64descendants
  • K113572Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012 · cites it directly62descendants
  • K133338Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013 · 2 generations on43descendants
  • K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien · 2014 · 2 generations on40descendants
  • K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015 · 2 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010010Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 &…Valleylab, Inc.2001—
+1K102470Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab,2011—
+1K113572Ligasure 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—
+2K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider…Covidien2014—
+2K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200610
200840
200910
201010
201130
201220
201330
201440
201560
2016110
201760
201880
201920
202050
2021100
202230
2023100
202420
202520
202650
FIG. 1 — Lineage of K010010, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (91)

See all 91

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

NumberDeviceApplicantDecidedDescendants
K102470Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab,201164
K113572Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H201262
K024286Gyrus Open ForcepsGyrus Medical, Inc.200314
K041587Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500Valleylab200411

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?

  • Of its descendants, K102470 (Covidien, Formerly Valleylab,, 2011) has gone furthest, with 64 descendants of its own.

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.

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—

More from Valleylab, Inc.

94 FDA decisions under this applicant name. See the company

  • K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 20032 recalls
  • K010013Ligasure Laparoscopic Sealer Divider Model LS1100Valleylab, Inc. · 20012 recalls
  • K994428E7512 Premie Rem Polyhesive II Patient Return ElectrodeValleylab, Inc. · 2000
  • K983743Bisure Laparoscopic Bipolar ForcepsValleylab, Inc. · 1999
  • K981916Ligasure Vessel Sealing SystemValleylab, Inc. · 1998

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K010010 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010010: Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010010

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026