510(k) · Cleared
ClearedLigaSure Retractable L-Hook Laparoscopic Sealer/Divider
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 Sep 16, 2016 as substantially equivalent to K150835 (Covidien, 2015) and 4 other predicates after a 78-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Sep 16, 2016
- Review
- 78 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K932293 (1994). 27 ancestors in all, the oldest K904560 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 6 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 5 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 4 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 3 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 2 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- 1 generation backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- This deviceK161804 LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −6 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −5 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −4 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −3 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −2 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| −1 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 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? (5)
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 |
|---|---|---|---|
| * | K150835 | LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol GripSummary page 4…sories (21 CFR § 878.4400, Class 11, GEI) Primary LigaSure™ Advance Monopolar Tip Sealer/Divider, Pistol Grip Bipolar and Monopolar Electrosurgical Instrument LF5544 K150835 (cleared 10/15/15); K063195 (clearance 11/29/06) Covidien This device has not been subject to a design-related recall Secondary… | 2015 |
| * | K063195 | Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Summary page 4…lass 11, GEI) Primary LigaSure™ Advance Monopolar Tip Sealer/Divider, Pistol Grip Bipolar and Monopolar Electrosurgical Instrument LF5544 K150835 (cleared 10/15/15); K063195 (clearance 11/29/06) Covidien This device has not been subject to a design-related recall Secondary LigaSure™ 5mm Maryland Jaw… | 2006 |
| * | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Summary page 4…ot been subject to a design-related recall Secondary LigaSure™ 5mm Maryland Jaw Sealer/Divider Bipolar and Monopolar Electrosurgical Instrument LF1723,LF1737, LF1744 K141153 (cleared 08/14/14); K133338 (cleared 12/20/13) Covidien This device has not been subject to a design-related recall Secondary… | 2014 |
| * | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Summary page 4…related recall Secondary LigaSure™ 5mm Maryland Jaw Sealer/Divider Bipolar and Monopolar Electrosurgical Instrument LF1723,LF1737, LF1744 K141153 (cleared 08/14/14); K133338 (cleared 12/20/13) Covidien This device has not been subject to a design-related recall Secondary Valleylab Laparoscopic Hands… | 2013 |
| * | K904560 | Valleylab Laparoscopic Handswitch/ElectrodesSummary page 4…12/20/13) Covidien This device has not been subject to a design-related recall Secondary Valleylab Laparoscopic Handswitch/Electrodes Monopolar Electrodes E2773-36 K904560 (cleared 12/31/1990) Covidien This device has not been subject to a design-related recall Traditional 510(k): LigaSure™ Retrac… | 1990 |
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 2.1 years on median.
- 7 of the 27 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. 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 Retractable L-Hook Laparoscopic Sealer/Divider is a 5mm 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 Sealer/Divider can be used on vessels (arteries and veins) up to and including 7mm in diameter. The monopolar L-Hook can be used to dissect through tissue planes and to create enterotomies…
Read the full statement (133 words)
The LigaSure Retractable L-Hook Laparoscopic Sealer/Divider is a 5mm 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 Sealer/Divider can be used on vessels (arteries and veins) up to and including 7mm
in diameter. The monopolar L-Hook can be used to dissect through tissue planes and to create enterotomies or
gastrotomies.
It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, colorectal, bariatric,
and gynecologic. Procedures may include, but are not limited to, gastric bypass, hysterectomy, Nissen fundoplication,
colectomy, cholecystectomy, adhesiolysis, oophorectomy, etc.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161804: LigaSure Retractable L-Hook Laparoscopic 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/K161804
Report an extraction error
Are you the manufacturer?
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