510(k) · Cleared
Recalled · 2011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 29, 2003 as substantially equivalent to K981916 (Valleylab, Inc., 1998) and 1 other predicate after a 59-day review. Its family tree reaches back 2 generations to 1994. 114 later devices descend from it. It has been recalled 2 times.
- Decided
- May 29, 2003
- Review
- 59 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932293 (1994). 8 ancestors in all. 114 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 1 generation backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- This deviceK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003
- Descendant · cites it directly · 65 of its ownK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · Recalled
- Descendant · cites it directly · 64 of its ownK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- Descendant · 2 generations on · 62 of its ownK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 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
- Descendant · 2 generations on · 42 of its ownK130744 Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerCovidien · 2013
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · cites it directly65descendants
- 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 · 2 generations on62descendants
- K133338Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013 · 2 generations on43descendants
- K130744Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerCovidien · 2013 · 2 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −1 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| 0 (this device) | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | — |
| +1 | K092879 | Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider | Valleylab | 2009 | 1 |
| +1 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| +2 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| +2 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| +2 | K130744 | Ligasure 5MM Blunt Tip Laparoscopic Sealer/Divider | Covidien | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 8 | 0 |
| 2016 | 12 | 0 |
| 2017 | 8 | 0 |
| 2018 | 11 | 0 |
| 2019 | 2 | 0 |
| 2020 | 8 | 0 |
| 2021 | 10 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981916 | Ligasure Vessel Sealing SystemSummary page 1…The Valleylab LigaSureTM5mm Laparoscopic Sealer-Divider is substantially equivalent to the Valleylab LSIOOO LigaSureTMLAP Laparoscopic Instrument (K981916), and the Valleylab LSIIOO LigaSure ATLASTMLaparoscopic Sealer- Divider Instrument (K010013). All three of these devices a… | 1998 |
| * | K010013 | Ligasure Laparoscopic Sealer Divider Model LS1100Summary page 1…to the Valleylab LSIOOO LigaSureTMLAP Laparoscopic Instrument (K981916), and the Valleylab LSIIOO LigaSure ATLASTMLaparoscopic Sealer- Divider Instrument (K010013). All three of these devices are used in laparoscopic surgery to seal vessels by the application of RF energy to the… | 2001 |
What descends from it? (114)
See all 1149 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092879 | Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider | 2009 | 65 |
| K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | 2011 | 64 |
| K063195 | Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034… | 2006 | 31 |
| K111202 | Surgical Tissue Management System | 2012 | 11 |
| K041587 | Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500 | 2004 | 11 |
| K110824 | Aragon Surgical RF System - 5MM Laparoscopic Instrument | 2011 | 7 |
| K081766 | PKS Omni Instrument | 2008 | 3 |
| K123096 | Reprocessed Vessel Sealer | 2013 | 1 |
| K062525 | Reprocessed Ligasure Vessel Sealer/Divider | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2011 | Not classified | Z-0640-2012 | Nonconforming Material/Component | Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching. |
| Nov 4, 2011 | Not classified | Z-0641-2012 | Nonconforming Material/Component | Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K092879 (Valleylab, 2009) has gone furthest, with 65 descendants of its own.
- 15 other devices also cite its predicate K981916.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 LigaSureTM5mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is surgeon- actuated to divide tissue.…
Read the full statement (161 words)
The LigaSureTM5mm Vessel Sealer-Divider is a bipolar electrosurgical instrument
intended for use with the LigaSure Generator in general and gynecologic laparoscopic
surgical procedures where ligation and division of vessels is desired. The instrument
creates a seal by application of RF electrosurgical energy to vascular structures (vessels)
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 laparoscopic procedures where ligation and
division of vessels is performed. These procedures include: laparoscopically assisted
vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc.
The LigaSure Vessel Sealing System 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 5mm Vessel Sealer-Divider can be used on vessels up to and including
7mm diameter, and tissue bundles as large as will fit in the jaws of the instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031011: Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031011
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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