510(k) · Cleared
Recalled · 2010Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 16, 2009 as substantially equivalent to K031011 (Valleylab, Inc., 2003) after a 28-day review. Its family tree reaches back 3 generations to 1994. 65 later devices descend from it. It has been recalled once.
- Decided
- Oct 16, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K932293 (1994). 9 ancestors in all. 65 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 2 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 1 generation backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- This deviceK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009
- Descendant · cites it directly · 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 · cites it directly · 42 of its ownK130744 Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerCovidien · 2013
- Descendant · 2 generations on · 40 of its ownK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- Descendant · 3 generations on · 14 of its ownK152286 LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015
- Descendant · 2 generations on · 11 of its ownK170869 LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K133338Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013 · cites it directly43descendants
- K130744Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerCovidien · 2013 · cites it directly42descendants
- 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 · 3 generations on14descendants
- K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −2 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −1 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| 0 (this device) | K092879 | Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider | Valleylab | 2009 | — |
| +1 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| +1 | K130744 | Ligasure 5MM Blunt Tip Laparoscopic Sealer/Divider | Covidien | 2013 | — |
| +2 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| +3 | K152286 | LigaSure Curved, Small Jaw, Open Sealer/Divider | Covidien | 2015 | — |
| +2 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | Covidien | 2017 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Summary page 1…ate Devices The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider is substantially equivalent to the LigaSure 5mm Laparoscopic Sealer and Divider submitter under K03 101 1. The substantial equivalence letter was dated 5/29/03. This Special 5 10(k) releases a blunt tip version of 5mm Laparoscopic… | 2003 |
What descends from it? (65)
See all 655 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | 2013 | 43 |
| K130744 | Ligasure 5MM Blunt Tip Laparoscopic Sealer/Divider | 2013 | 42 |
| K141288 | Voyant Electrosurgical Generator, Voyant 5MM Laparoscopic Sealer-Divider Device | 2014 | 9 |
| K110824 | Aragon Surgical RF System - 5MM Laparoscopic Instrument | 2011 | 7 |
| K123096 | Reprocessed Vessel Sealer | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 8, 2010 | Not classified | Z-0954-2011 | Device Design | During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K133338 (Covidien, Formerly Valleylab, A Division of Tyco H, 2013) has gone furthest, with 43 descendants of its own.
- 8 other devices also cite its predicate K031011.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 5mm, Blunt tip, Laparoscopic Sealer-Divider is a bipolar electrosurgical instrument intended for use the ForceTriad Generator 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…
Read the full statement (166 words)
The LigaSure 5mm, Blunt tip, Laparoscopic Sealer-Divider is a bipolar electrosurgical instrument intended for use the ForceTriad Generator 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 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 5mm Blunt tip Laparoscopic Sealer-Divider can be used on vessels and lymphatics up to and including 7mm 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/K092879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092879: Ligasure 5MM Blunt Tip Laparoscopic 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/K092879
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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