510(k) · Cleared
ClearedLigasure Vessel Sealing System. Ligasure Instruments
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 Jan 5, 2005 as substantially equivalent to K981916 (Valleylab, Inc., 1998) after a 40-day review. Its family tree reaches back 2 generations to 1994. 37 later devices descend from it.
- Decided
- Jan 5, 2005
- Review
- 40 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932293 (1994). 7 ancestors in all. 37 later devices descend from it, 5 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 deviceK043273 Ligasure Vessel Sealing System. Ligasure InstrumentsValleylab · 2005
- Descendant · cites it directly · 31 of its ownK063195 Ligasure Advance Laparoscopic Sealer/Divider with Dissecting…Valleylab · 2006
- Descendant · 2 generations on · 24 of its ownK081129 Enseal…Surgrx, Inc. · 2008
- Descendant · 3 generations on · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
- Descendant · 3 generations on · 11 of its ownK101990 Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011
- Descendant · 4 generations on · 9 of its ownK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K063195Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Valleylab · 2006 · cites it directly31descendants
- K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc. · 2008 · 2 generations on24descendants
- K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · 3 generations on11descendants
- K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011 · 3 generations on11descendants
- K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014 · 4 generations on9descendants
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) | K043273 | Ligasure Vessel Sealing System. Ligasure Instruments | Valleylab | 2005 | — |
| +1 | K063195 | Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models… | Valleylab | 2006 | — |
| +2 | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | Surgrx, Inc. | 2008 | — |
| +3 | K111202 | Surgical Tissue Management System | Olympus Medical Systems Corp. | 2012 | 10 |
| +3 | K101990 | Ethicon Endo-Surgery Generator G11, Model GEN11 | Ethicon Endo-Sugery, LLC | 2011 | — |
| +4 | K141122 | Harmonic Scallop Blade, Generator G11 | Ethicon Endo-Surgery, LLC | 2014 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K981916 | Ligasure Vessel Sealing SystemSummary page 1…essel Sealing System is substantially equivalent to the following legally marketed medical devices: * LigaSure TM Vessel Sealing System (K981916) 4. Device Description The LigaSure TM Vessel Sealing System consists of a microprocessor-based radio-… | 1998 |
What descends from it? (37)
See all 375 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063195 | Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034… | 2006 | 31 |
| K141484 | Open Fmsealer | 2014 | 1 |
| K082109 | Bovie Icon General Purpose RF Generator | 2008 | 1 |
| K160331 | LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable… | 2016 | 0 |
| K142229 | Laparoscopic FMsealer | 2015 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K063195 (Valleylab, 2006) has gone furthest, with 31 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 LigaSure TM Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph 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…
Read the full statement (176 words)
The LigaSure TM Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph 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 urologic, 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 7mm and bundles as large as will fit in the jaws of the instruments.
The LigaSureTM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043273: Ligasure Vessel Sealing System. Ligasure Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043273
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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