510(k) · Cleared
ClearedLigasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500
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 Sep 28, 2004 as substantially equivalent to K010010 (Valleylab, Inc., 2001) and 1 other predicate after a 106-day review. Its family tree reaches back 3 generations to 1994. 11 later devices descend from it.
- Decided
- Sep 28, 2004
- Review
- 106 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932293 (1994). 10 ancestors in all. 11 later devices descend from it, 1 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 deviceK041587 Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer…Valleylab · 2004
- Descendant · cites it directly · 10 of its ownK081312 Aragon Oneshot SystemAragon Surgical, Inc. · 2008
- Descendant · 2 generations on · 9 of its ownK090306 Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc. · 2009
- Descendant · 3 generations on · 7 of its ownK110824 Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc. · 2011
- Descendant · 3 generations on · 7 of its ownK093075 Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 6 of its ownK130596 Caiman Seal and Cut TechnologyAesculap, Inc. · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K081312Aragon Oneshot SystemAragon Surgical, Inc. · 2008 · cites it directly10descendants
- K090306Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc. · 2009 · 2 generations on9descendants
- K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc. · 2011 · 3 generations on7descendants
- K093075Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 2010 · 3 generations on7descendants
- K130596Caiman Seal and Cut TechnologyAesculap, Inc. · 2013 · 3 generations on6descendants
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) | K041587 | Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model… | Valleylab | 2004 | — |
| +1 | K081312 | Aragon Oneshot System | Aragon Surgical, Inc. | 2008 | — |
| +2 | K090306 | Aragon Surgical RF System L2 Instrument | Aragon Surgical, Inc. | 2009 | — |
| +3 | K110824 | Aragon Surgical RF System - 5MM Laparoscopic Instrument | Aragon Surgical, Inc. | 2011 | — |
| +3 | K093075 | Aragon Surgical RF System Teleo Instrument | Aragon Surgical, Inc. | 2010 | 2 |
| +3 | K130596 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K010010 | Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure… | 2001 |
| * | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Summary page 1…• For cutting capabilities, the LS41IOO is substantially equivalent to the Valleylab LS1500 LigaSure TM 5mm Laparoscopic Sealer-Divider Instrument (K03101 1) 4. Device Description The LigaSure Open Dissector Divider is a multi-functional, electrosurgical inst… | 2003 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081312 | Aragon Oneshot System | 2008 | 10 |
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 10 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K081312 (Aragon Surgical, Inc., 2008) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K010010.
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 LigaSureTM Open Dissector Divider is a bipolar electrosurgical instrument intended for use with the LigaSureTM Generator in open, general, surgical procedures where dissection, ligation and division of vessels is desired. This device creates ligation by application of bipolar electrosurgical RF energy and pressure to vessels/tissue interposed between the jaws of the device. The ligation can then be transected using the built in cutting mechanism. The…
Read the full statement (158 words)
The LigaSureTM Open Dissector Divider is a bipolar electrosurgical instrument intended for use with the LigaSureTM Generator in open, general, surgical procedures where dissection, ligation and division of vessels is desired. This device creates ligation by application of bipolar electrosurgical RF energy and pressure to vessels/tissue interposed between the jaws of the device. The ligation can then be transected using the built in cutting mechanism. The device can be used for vessels up to and including 7 mm in diameter and tissue bundles as large as will fit into the jaws of the instrument.
Indications for use include general, open procedures including urologic, vascular, thoracic, and plastic and reconstructive, procedures where dissection, ligation and division of vessels are performed such as: spleenectomies, thryoidectomies, nephrectomies, prostatectomies, bowel resection and colectomy.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041587 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041587: Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041587
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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