510(k) · Cleared
ClearedLigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip
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 Oct 15, 2015 as substantially equivalent to K063195 (Valleylab, 2006) after a 199-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Oct 15, 2015
- Review
- 199 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932293 (1994). 13 ancestors in all, the oldest K904560 (1990). 1 later device descends from it, 1 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 backK063195 Ligasure Advance Laparoscopic Sealer/Divider with Dissecting…Valleylab · 2006
- This deviceK150835 LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol…Covidien · 2015
- Descendant · cites it directly · 0 of its ownK161804 LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien · 2016
Most influential descendants
Showing 1 of 1 · See all- K161804LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien · 2016 · cites it directly0descendants
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 | K063195 | Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models… | Valleylab | 2006 | — |
| 0 (this device) | K150835 | LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip | Covidien | 2015 | — |
| +1 | K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider | Covidien | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K063195 | Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Summary page 4…edicate Device The subject device is a legally marketed medical device, manufactured by Covidien llc. The LigaSure Advance family of instruments was cleared under 510(k) K063195. The original LigaSure Advance Monopolar tip devices (LF5034 and LF5044) are the predicate devices for the purpose of this 510(k)… | 2006 |
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 |
|---|---|---|---|
| K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider | 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 21 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K161804 (Covidien, 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K063195.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Advance Sealer/Divider is a bipolar/monopolar electrosurgical instrument intended for use in minimally invasive surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Advance Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. The instrument can be used to dissect through tissuc planes and to create enterotomies or gastrotomies. It is indicated for…
Read the full statement (129 words)
The LigaSure Advance Sealer/Divider is a bipolar/monopolar electrosurgical instrument intended for use in minimally invasive surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Advance Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. The instrument can be used to dissect through tissuc planes and to create enterotomies or gastrotomies.
It is indicated for use in gencral surgery and such surgical specialties as urologic, vascular, thoracic, colorectal, bariatric, and gynecologic. Procedures may include, but are not limited to, gastric bypass, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
The LigaSure™ system has not been shown to be effective for tubal sterilization or tubal coagulation for stetilization procedures. Do not use the LigaSure system for these procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150835: LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150835
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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