510(k) · Cleared
ClearedLigasure Vessel Sealing System
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 Aug 28, 1998 as substantially equivalent to K944602 (Valleylab, Inc., 1995) and 5 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1994. 202 later devices descend from it.
- Decided
- Aug 28, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 1 generation to K932293 (1994). 6 ancestors in all. 202 later devices descend from it, 16 citing it directly.
- Root · 1 generation backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- This deviceK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- Descendant · cites it directly · 128 of its ownK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
- Descendant · cites it directly · 114 of its ownK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 102 of its ownK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
- Descendant · 2 generations on · 65 of its ownK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · Recalled
- Descendant · 2 generations on · 64 of its ownK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
Showing 5 of 202 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 202 · See all- K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005 · cites it directly128descendants
- K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · cites it directly114descendants
- K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007 · 2 generations on102descendants
- K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · 2 generations on65descendants
- K102470Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011 · 2 generations on64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| 0 (this device) | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| +1 | K051644 | Valleylab Forcetriad Electrosurgical Generator | Valleylab | 2005 | — |
| +1 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| +2 | K070162 | Forcetriad Electrosurgical Generator; Ligasure Instruments | Valleylab,A Division of Tyco Healthcare Group LP | 2007 | — |
| +2 | K092879 | Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider | Valleylab | 2009 | 1 |
| +2 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 10 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 13 | 0 |
| 2018 | 18 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 12 | 0 |
| 2022 | 10 | 0 |
| 2023 | 12 | 0 |
| 2024 | 11 | 0 |
| 2025 | 7 | 0 |
| 2026 | 10 | 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? (7)
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 |
|---|---|---|---|
| * | K944602 | Valleylab Force FXSummary page 1…Devices The LigaSure™ Vessel Sealing Generator is a bipolar generator which is substantially equivalent to the following Valleylab electrosurgical generators: Force FX (K944602), Force 300 (K953195) and N'S2000 (K946177). The LigaSure™ Open and Laparoscopic Instruments are substantially equivalent to the… | 1995 |
| * | K953195 | Valleylab Force 300Summary page 1…™ Vessel Sealing Generator is a bipolar generator which is substantially equivalent to the following Valleylab electrosurgical generators: Force FX (K944602), Force 300 (K953195) and N'S2000 (K946177). The LigaSure™ Open and Laparoscopic Instruments are substantially equivalent to the Cabot Seitzinger Tri… | 1995 |
| * | K946177 | Valleylab NS 2000 Bipolar Generator SystemSummary page 1…ator is a bipolar generator which is substantially equivalent to the following Valleylab electrosurgical generators: Force FX (K944602), Force 300 (K953195) and N'S2000 (K946177). The LigaSure™ Open and Laparoscopic Instruments are substantially equivalent to the Cabot Seitzinger Tripolar Forceps, the Cab… | 1995 |
| * | K932293 | Cabot Medical Bipolar Cutting ForcepsSummary page 1…000 (K946177). The LigaSure™ Open and Laparoscopic Instruments are substantially equivalent to the Cabot Seitzinger Tripolar Forceps, the Cabot Bipolar Cutting Forceps (K932293 and K946109) and the Storz Bipolar Forceps (K960009). All of these devices perform the coagulation of tissue via bipolar RF energ… | 1994 |
| * | K946109 | Cabot Medical Reusable Bipolar Cutting ForcepsSummary page 1…). The LigaSure™ Open and Laparoscopic Instruments are substantially equivalent to the Cabot Seitzinger Tripolar Forceps, the Cabot Bipolar Cutting Forceps (K932293 and K946109) and the Storz Bipolar Forceps (K960009). All of these devices perform the coagulation of tissue via bipolar RF energy applied th… | 1995 |
| * | K960009 | Storz S2050 Series Bipolar ForcepsSummary page 1…Instruments are substantially equivalent to the Cabot Seitzinger Tripolar Forceps, the Cabot Bipolar Cutting Forceps (K932293 and K946109) and the Storz Bipolar Forceps (K960009). All of these devices perform the coagulation of tissue via bipolar RF energy applied through the electrodes of the devices. IV… | 1996 |
| * | — | Cabot Seitzinger Tripolar Forceps Named without a submission number |
What descends from it? (202)
See all 20216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051644 | Valleylab Forcetriad Electrosurgical Generator | 2005 | 128 |
| K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | 2003 | 114 |
| K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller… | 2003 | 56 |
| K043273 | Ligasure Vessel Sealing System. Ligasure Instruments | 2005 | 37 |
| K024286 | Gyrus Open Forceps | 2003 | 14 |
| K081312 | Aragon Oneshot System | 2008 | 10 |
| K090306 | Aragon Surgical RF System L2 Instrument | 2009 | 9 |
| K123662 | The Justright Surgical Vessel Sealing System | 2013 | 7 |
| K110824 | Aragon Surgical RF System - 5MM Laparoscopic Instrument | 2011 | 7 |
| K160602 | JustRight Surgical Vessel Sealing System | 2016 | 6 |
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?
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 LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic procedures where ligation of vessels is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar…
Read the full statement (142 words)
The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic procedures where ligation of vessels is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device.
The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.
The indications for use include general, (including uroclogic, thoracic,plastic and reconstructive), laparoscopic and gynecological procedures where ligation of vessels is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels up to 7 mm. and bundles as large as will fit in the jaws of the instruments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981916 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981916: Ligasure Vessel Sealing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981916
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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