510(k) · Cleared
ClearedLigaSure™ XP Maryland Jaw Sealer/Divider
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 Jan 23, 2023 as substantially equivalent to K170869 (Covidien, 2017) and 1 other predicate after a 108-day review. Its family tree reaches back 9 generations to 1994. 1 later device descends from it.
- Decided
- Jan 23, 2023
- Review
- 108 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K932293 (1994). 25 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 5 generations between
- 3 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 2 generations backK142929 Ligasure Blunt Tip Sealer/DividerCovidien · 2015
- 1 generation backK162941 Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien · 2016 · Recalled
- This deviceK223158 LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC · 2023
- Descendant · cites it directly · 0 of its ownK260636 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without…Stryker Sustainability Solutions · 2026
Show all 9 generations
- Root · 9 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 8 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 7 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 6 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 5 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 4 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- 3 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 2 generations backK142929 Ligasure Blunt Tip Sealer/DividerCovidien · 2015
- 1 generation backK162941 Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien · 2016 · Recalled
- This deviceK223158 LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −8 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −7 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −6 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −5 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −4 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| −3 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| −2 | K142929 | Ligasure Blunt Tip Sealer/Divider | Covidien | 2015 | — |
| −1 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | Covidien | 2016 | 1 |
| 0 (this device) | K223158 | LigaSure™ XP Maryland Jaw Sealer/Divider | Covidien, LLC | 2023 | — |
| +1 | K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | 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 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedSummary page 4…21 CFR 878.4400, Class II, GEI) Predicate Devices The primary predicate device is the LigaSure™ Maryland Jaw Sealer/Divider, One-Step Sealing, Nano-Coated cleared under K170869 and the secondary predicate device is the LigaSure™ Blunt Tip Sealer/Divider, Nano-Coated cleared under K162941. Primary Trade N… | 2017 |
| * | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coatedSummary page 4…aler/Divider, One-Step Sealing, Nano-Coated cleared under K170869 and the secondary predicate device is the LigaSure™ Blunt Tip Sealer/Divider, Nano-Coated cleared under K162941. Primary Trade Name: LigaSure™ Maryland Jaw Sealer/Divider, One-Step Sealing, Nano-Coated Catalog Numbers: LF1923,… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | 2026 | 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 29 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 25 ancestors have a recall of any class.
- Of its descendants, K260636 (Stryker Sustainability Solutions, 2026) has gone furthest, with 0 descendants of its own.
- 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. 2023, 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 XP Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure XP Maryland Jaw 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 such surgical specialties as colorectal…
Read the full statement (130 words)
The LigaSure XP Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure XP Maryland Jaw 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 such surgical specialties as colorectal, bariatric, urologic, vascular, thoracic, and gynecologic. These may include, but are not limited to, such procedures as Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, and so forth.
The LigaSure XP Maryland Jaw Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure XP Maryland Jaw Sealer/Divider for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223158: LigaSure™ XP Maryland Jaw Sealer/Divider.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223158
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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