510(k) · Cleared
ClearedLaparoscopic Electrosurgical Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everest Medical Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 25, 1991 after a 79-day review. The FDA summary names no predicate by number. 6 of the 266 devices in its family, counting itself, have a Class I recall. 265 later devices descend from it.
- Decided
- Jan 25, 1991
- Review
- 79 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
265 later devices descend from it, 12 citing it directly. 6 of the 266 devices in this family, counting this one, have a Class I recall.
- This deviceK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
- Descendant · cites it directly · 155 of its ownK031080 Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons…Gyrus Medical, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 154 of its ownK061260 Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 &…Intuitive Surgical, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 153 of its ownK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 148 of its ownK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 124 of its ownK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
Showing 5 of 265 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 265 · See all- K031080Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting ForcepsGyrus Medical, Inc. · 2003 · cites it directly155descendants
- K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc. · 2006 · 2 generations on154descendants
- K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc. · 2009 · 3 generations on153descendants
- K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · 4 generations on148descendants
- K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · 4 generations on124descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904993 | Laparoscopic Electrosurgical Device | Everest Medical Corp. | 1991 | — |
| +1 | K031080 | Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting… | Gyrus Medical, Inc. | 2003 | 1 |
| +2 | K061260 | Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214 | Intuitive Surgical, Inc. | 2006 | 1 |
| +3 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| +4 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| +4 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 7 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 1 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 1 |
| 2011 | 5 | 1 |
| 2012 | 7 | 1 |
| 2013 | 5 | 0 |
| 2014 | 13 | 0 |
| 2015 | 5 | 0 |
| 2016 | 15 | 1 |
| 2017 | 13 | 0 |
| 2018 | 12 | 0 |
| 2019 | 8 | 0 |
| 2020 | 19 | 0 |
| 2021 | 15 | 0 |
| 2022 | 16 | 0 |
| 2023 | 23 | 1 |
| 2024 | 23 | 0 |
| 2025 | 35 | 0 |
| 2026 | 22 | 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.
6 devices in this family have a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (265)
See all 26512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031080 | Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting Forceps | 2003 | 155 |
| K030512 | Guidant Vasoview Endoscopic Vessel Harvesting System | 2003 | 62 |
| K031079 | Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode | 2003 | 35 |
| K031082 | Everest Bipolar L Hook & PK Bipolar L Hook | 2003 | 15 |
| K031078 | Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro, Micro & Molly Forceps | 2003 | 5 |
| K023493 | PK Zip Wing Cutting Dissector | 2002 | 4 |
| K023492 | Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Forceps | 2002 | 4 |
| K030578 | Bipolar Grasper and Bipolar Scissors for the Zeus Microwrist Surgical System | 2003 | 0 |
| K031081 | Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors | 2003 | 0 |
| K020585 | Zip Open Forceps with Electrosurgical Cut | 2002 | 0 |
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K052274Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Guidant Corporation · 2005 · 2 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
- K101274Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K031080 (Gyrus Medical, Inc., 2003) has gone furthest, with 155 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K904993 · printed Nov 5, 2026
Cite this page
510(k) Report. “K904993: Laparoscopic Electrosurgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904993
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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