510(k) · Cleared
ClearedLigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 15, 2026 as substantially equivalent to K170869 (Covidien, 2017) after a 167-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Sep 15, 2026
- Review
- 167 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K932293 (1994). 23 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 backK170869 LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017
- This deviceK261070 LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
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 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | Covidien | 2017 | — |
| 0 (this device) | K261070 | LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 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? (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 |
|---|---|---|---|
| * | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedSummary page 5…Vessel Sealing Device Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400) Regulatory Class: II Product Code: GEI 510(k): K170869 (cleared: April 21, 2017) Manufacturer: Covidien llc Reference Device Trade Name: HugoTM RAS Bipolar Maryland Forceps (cleared u… | 2017 |
| † | K250725 | Hugo™ RAS System | 2025 |
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 32 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 6 of the 23 ancestors have a recall of any class.
- 6 other devices also cite its predicate K170869.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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™ Robotically Assisted Surgery (RAS) Maryland Jaw Vessel Sealer/Divider is a bipolar electrosurgical instrument intended for use with the Hugo™ RAS System where ligation, and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use with the Hugo™ RAS System during the…
Read the full statement (127 words)
The LigaSure™ Robotically Assisted Surgery (RAS) Maryland Jaw Vessel Sealer/Divider is a bipolar electrosurgical instrument intended for use with the Hugo™ RAS System where ligation, and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use with the Hugo™ RAS System during the representative surgical procedures set forth in the Hugo™ RAS System Indications Document and the Hugo™ RAS System User’s Guide Instrument Addendum.
The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261070 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261070: LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261070
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026