510(k) · Cleared
ClearedForcetriad Electrosurgical Generator; Ligasure Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab,A Division of Tyco Healthcare Group LP · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 6, 2007 as substantially equivalent to K051644 (Valleylab, 2005) after a 48-day review. Its family tree reaches back 3 generations to 1994. 102 later devices descend from it.
- Decided
- Mar 6, 2007
- Review
- 48 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K932293 (1994). 8 ancestors in all. 102 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 2 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 1 generation backK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
- This deviceK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
- Descendant · cites it directly · 56 of its ownK123444 Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2013
- Descendant · 2 generations on · 40 of its ownK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- Descendant · cites it directly · 16 of its ownK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
- Descendant · 3 generations on · 14 of its ownK152286 LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015
- Descendant · 3 generations on · 11 of its ownK170869 LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K123444Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2013 · cites it directly56descendants
- K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien · 2014 · 2 generations on40descendants
- K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011 · cites it directly16descendants
- K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015 · 3 generations on14descendants
- K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien · 2017 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −2 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −1 | K051644 | Valleylab Forcetriad Electrosurgical Generator | Valleylab | 2005 | — |
| 0 (this device) | K070162 | Forcetriad Electrosurgical Generator; Ligasure Instruments | Valleylab,A Division of Tyco Healthcare Group LP | 2007 | — |
| +1 | K123444 | Ligasure Impact Curved, Large Jaw, Open Sealer / Divider | 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 | K110268 | Forcetriad Electrosurgical Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011 | — |
| +3 | K152286 | LigaSure Curved, Small Jaw, Open Sealer/Divider | Covidien | 2015 | — |
| +3 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | Covidien | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 12 | 0 |
| 2017 | 9 | 0 |
| 2018 | 12 | 0 |
| 2019 | 3 | 0 |
| 2020 | 8 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K051644 | Valleylab Forcetriad Electrosurgical GeneratorSummary page 1…rgical Generator is substantially equivalent to the following legally marketed medical devices: .ForceTriad Tm Electrosurgical Generator (K051644) 4. Device Description The ForceTriadTM generator is a full-featured electrosurgical generator with monopolar,… | 2005 |
What descends from it? (102)
See all 1029 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123444 | Ligasure Impact Curved, Large Jaw, Open Sealer / Divider | 2013 | 56 |
| K110268 | Forcetriad Electrosurgical Generator | 2011 | 16 |
| K111202 | Surgical Tissue Management System | 2012 | 11 |
| K141288 | Voyant Electrosurgical Generator, Voyant 5MM Laparoscopic Sealer-Divider Device | 2014 | 9 |
| K123662 | The Justright Surgical Vessel Sealing System | 2013 | 7 |
| K110824 | Aragon Surgical RF System - 5MM Laparoscopic Instrument | 2011 | 7 |
| K160602 | JustRight Surgical Vessel Sealing System | 2016 | 6 |
| K120040 | Reprocessed Surgical Electric Instrument | 2012 | 0 |
| K111600 | Reprocessed Hand Activate Sealer/Divider | 2011 | 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 13 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K123444 (Covidien, Formerly Valleylab, A Division of Tyco H, 2013) has gone furthest, with 56 descendants of its own.
- 6 other devices also cite its predicate K051644.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ForceTriadTM is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting, coagulation, or vessel sealing (tissue fusion). The generator is intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of…
Read the full statement (212 words)
The ForceTriadTM is a full-featured electrosurgical generator intended for
open and laparoscopic surgical procedures where the surgeon requires
electrosurgical cutting, coagulation, or vessel sealing (tissue fusion). The
generator is intended for use in general, laparoscopic and gynecologic
surgical procedures where ligation of vessels, pulmonary vasculature, or
lymph vessels, is desired. The system creates a vessel ligation (seal) by
the application of bipolar electrosurgical RF energy (coagulation) to
vessels interposed between the jaws of the device. The generator can
also be used with standard bipolar devices where bipolar cutting or
coagulation is desired.
The indications for use include general (including urologic, thoracic, plastic
and reconstructive), laparoscopic, and gynecological procedures where
electrosurgical cutting and coagulation of tissue, and sealing (fusion) of
vessels, including pulmonary vessels, and tissue bundles is performed,
including such procedures as bowel resections, hysterectomies (both
vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically
assisted vaginal hysterectomies, gall bladder procedures, Nissen
fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used
on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up
to 7mm and bundles as large as will fit in the jaws of the instruments.
The LigaSure tissue fusion function has not been shown to be effective for
tubal sterilization or tubal coagulation for sterilization procedures. Do not
use this function for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070162: Forcetriad Electrosurgical Generator; Ligasure Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070162
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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