510(k) · Cleared
ClearedLigasure Curved, Small Jaw, Open Sealer/Divider
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly Valleylab, A Division of Tyco H · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 5, 2012 as substantially equivalent to K102470 (Covidien, Formerly Valleylab,, 2011) and 1 other predicate after a 278-day review. Its family tree reaches back 4 generations to 1994. 62 later devices descend from it.
- Decided
- Sep 5, 2012
- Review
- 278 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K932293 (1994). 11 ancestors in all. 62 later devices descend from it, 9 citing it directly.
- Root · 4 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 3 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 2 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 1 generation backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- This deviceK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 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 · 40 of its ownK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- Descendant · cites it directly · 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
- Descendant · cites it directly · 9 of its ownK132703 ThunderbeatOlympus Medical Systems Corp. · 2014
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · 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
- K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien · 2014 · cites it directly40descendants
- K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015 · cites it directly14descendants
- K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017 · 2 generations on11descendants
- K132703ThunderbeatOlympus Medical Systems Corp. · 2014 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −3 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −2 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −1 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| 0 (this device) | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| +1 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| +1 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| +1 | K152286 | LigaSure Curved, Small Jaw, Open Sealer/Divider | Covidien | 2015 | — |
| +2 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | Covidien | 2017 | — |
| +1 | K132703 | Thunderbeat | Olympus Medical Systems Corp. | 2014 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 9 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2020 | 3 | 0 |
| 2021 | 10 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K102470 | Lugasure Curved, Small Jaw, Open Sealer/DividerSummary page 1…n is required. There were no physical changes made to the device associated with the proposed expanded indication; the device design is unchanged from that cleared under K102470. This submission followed the "Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, 2005," the "G… | 2011 |
| * | K010010 | Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure…Summary page 1…ument Vessel Sealing System Device Common Name: Bipolar electrosurgical instrument Catalog Number: LS1 200 510(k) Number: K010010 (cleared 4/2/2001) Manufacturer: Covidien, formerly Valleylab. a division of Tyco Healthcare Device Descriptio… | 2001 |
What descends from it? (62)
See all 629 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 |
| K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw… | 2014 | 40 |
| K152286 | LigaSure Curved, Small Jaw, Open Sealer/Divider | 2015 | 14 |
| K132703 | Thunderbeat | 2014 | 9 |
| K151743 | THUNDERBEAT Open Fine Jaw | 2016 | 6 |
| K131435 | Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio… | 2013 | 5 |
| K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | 2020 | 4 |
| K153017 | Voyant Fine Fusion | 2016 | 1 |
| K160331 | LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable… | 2016 | 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 18 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 11 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.
- 4 other devices also cite its predicate K102470.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Curved, Small Jaw, Open Sealer / Divider is a bipolar electrosurgical instrument intended to be used with the ForceTriad energy platform. The instrument is indicated for use in open general surgical procedures where ligation and division of vessels (up to 7 mm in diameter), tissue bundles, and lymphatics is performed, such as urologic, thoracic, plastic, and reconstructive; and including such procedures as bowel resections, gall bladder…
Read the full statement (143 words)
The LigaSure Curved, Small Jaw, Open Sealer / Divider is a bipolar electrosurgical instrument intended to be used with the ForceTriad energy platform. The instrument is indicated for use in open general surgical procedures where ligation and division of vessels (up to 7 mm in diameter), tissue bundles, and lymphatics is performed, such as urologic, thoracic, plastic, and reconstructive; and including such procedures as bowel resections, gall bladder procedures, Nissen fundoplication, adhesiolysis, etc.
The device is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113572: Ligasure Curved, Small Jaw, Open Sealer/Divider.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113572
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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