510(k) · Cleared
ClearedLigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 12, 2016 as substantially equivalent to K043273 (Valleylab, 2005) and 5 other predicates after a 186-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Aug 12, 2016
- Review
- 186 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K932293 (1994). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 7 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 6 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 5 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 4 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 3 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- 2 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 1 generation backK152286 LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015
- This deviceK160331 LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved…Covidien · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −7 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −6 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −5 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −4 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −3 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| −2 | 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 | — |
| 0 (this device) | K160331 | LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open… | Covidien | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (6)
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 |
|---|---|---|---|
| * | K043273 | Ligasure Vessel Sealing System. Ligasure InstrumentsSummary page 5…Name: LigaSure™ Standard Instrument Common Name: Bipolar Vessel Sealing Device Catalog Number: LS2070, LS2071 510(k) Number: K043273 (cleared 01/05/2005), K981916 (cleared 08/28/1998) Manufacturer: Covidien Recall: This device has n… | 2005 |
| * | K981916 | Ligasure Vessel Sealing SystemSummary page 5…ndard Instrument Common Name: Bipolar Vessel Sealing Device Catalog Number: LS2070, LS2071 510(k) Number: K043273 (cleared 01/05/2005), K981916 (cleared 08/28/1998) Manufacturer: Covidien Recall: This device has not been subject to a design-re… | 1998 |
| * | K152286 | LigaSure Curved, Small Jaw, Open Sealer/DividerSummary page 5…: LigaSure™ Curved, Small Jaw, Open Sealer/Divider Common Name: Bipolar Vessel Sealing Device Catalog Number: LF1212A 510(k) Number: K152286 (cleared 09/08/2015), K141153 (cleared 8/14/2014), K113572 (cleared 9/5/2012), K102470 (cleared 2/7/2011)… | 2015 |
| * | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Summary page 5…mall Jaw, Open Sealer/Divider Common Name: Bipolar Vessel Sealing Device Catalog Number: LF1212A 510(k) Number: K152286 (cleared 09/08/2015), K141153 (cleared 8/14/2014), K113572 (cleared 9/5/2012), K102470 (cleared 2/7/2011) Manufacturer: Covid… | 2014 |
| * | K113572 | Ligasure Curved, Small Jaw, Open Sealer/DividerSummary page 5…Common Name: Bipolar Vessel Sealing Device Catalog Number: LF1212A 510(k) Number: K152286 (cleared 09/08/2015), K141153 (cleared 8/14/2014), K113572 (cleared 9/5/2012), K102470 (cleared 2/7/2011) Manufacturer: Covidien Recalls: T… | 2012 |
| * | K102470 | Lugasure Curved, Small Jaw, Open Sealer/DividerSummary page 5…ce Catalog Number: LF1212A 510(k) Number: K152286 (cleared 09/08/2015), K141153 (cleared 8/14/2014), K113572 (cleared 9/5/2012), K102470 (cleared 2/7/2011) Manufacturer: Covidien Recalls: This device has not been subject to a design-related… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 6 of the 24 ancestors have a recall of any class.
- 4 other devices also cite its predicate K043273.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Sealer/Divider, comprised of a single use electrode and a reusable clamp, is intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Electrode is a single use component that attaches to the LigaSure Clamp. After assembly, the LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general…
Read the full statement (218 words)
The LigaSure Sealer/Divider, comprised of a single use electrode and a reusable clamp, is intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
The LigaSure Electrode is a single use component that attaches to the LigaSure Clamp. After assembly, the LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, reconstructive, and gynecologic. Procedures may include, but are not limited to, bowel resections, hysterectomy, oophorectomy, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
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.
The LigaSure Sealer/Divider, comprised of a single use electrode and a reusable clamp, is intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
The LigaSure Clamp is a reusable handpiece to which the LigaSure Electrode attaches. Refer to the labeling of the compatible electrode for specific indications.
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/K160331 · printed Nov 3, 2026
Cite this page
510(k) Report. “K160331: LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K160331
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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