510(k) · Cleared
ClearedRemanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 18, 2026 as substantially equivalent to K223158 (Covidien, LLC, 2023) after a 112-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Jun 18, 2026
- Review
- 112 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K932293 (1994). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 6 generations between
- 3 generations backK142929 Ligasure Blunt Tip Sealer/DividerCovidien · 2015
- 2 generations backK162941 Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien · 2016 · Recalled
- 1 generation backK223158 LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC · 2023
- This deviceK260636 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without…Stryker Sustainability Solutions · 2026
Show all 10 generations
- Root · 10 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 9 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 8 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 7 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 6 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 5 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- 4 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 3 generations backK142929 Ligasure Blunt Tip Sealer/DividerCovidien · 2015
- 2 generations backK162941 Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien · 2016 · Recalled
- 1 generation backK223158 LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC · 2023
- This deviceK260636 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without…Stryker Sustainability Solutions · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −9 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −8 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −7 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −6 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −5 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| −4 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| −3 | K142929 | Ligasure Blunt Tip Sealer/Divider | Covidien | 2015 | — |
| −2 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | Covidien | 2016 | 1 |
| −1 | K223158 | LigaSure™ XP Maryland Jaw Sealer/Divider | Covidien, LLC | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K223158 | LigaSure™ XP Maryland Jaw Sealer/DividerSummary page 5…Number 510(k) Title Number Manufacturer LXMJ23L LXMJ37L LXMJ44L K223158 LigaSure XP Maryland Jaw Sealer/Divider Covidien LXMJ23S LXMJ37S LXMJ44S Device Description: The Remanu… | 2023 |
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 7 companies; a new generation was cleared every 3.4 years on median.
- 7 of the 26 ancestors have a recall of any class.
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 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating 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 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use…
Read the full statement (142 words)
The Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating 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 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating 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 Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the Remanufactured LigaSure XP Maryland Jaw Sealer/Divider without Nano-coating for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260636: Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260636
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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