510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting Forceps

K031080510(k) SpecialCleared May 16, 200342-day reviewClass II21 CFR 878.4400Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gyrus Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 16, 2003 as substantially equivalent to K904993 (Everest Medical Corp., 1991) after a 42-day review. Its family tree reaches back 1 generation to 1991. 1 of the 157 devices in its family, counting itself, has a Class I recall. 155 later devices descend from it. It has been recalled once.

Decided
May 16, 2003
Review
42 days
Class
Class II
Product code
GEI
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K904993 (1991). 155 later devices descend from it, 1 citing it directly. 1 of the 157 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2006: 1 descendant cleared2009: 1 descendant cleared2014: 5 descendants cleared2017: 7 descendants cleared2012: 1 descendant cleared2019: 5 descendants cleared2018: 9 descendants cleared2016: 7 descendants cleared2020: 12 descendants cleared2021: 12 descendants cleared2022: 13 descendants cleared2011: 1 descendant cleared2025: 26 descendants cleared2024: 18 descendants cleared2015: 2 descendants cleared2026: 18 descendants cleared2023: 17 descendants cleared, 1 with a Class I recall1K904993 · Laparoscopic Electrosurgical Device · Everest Medical Corp. · 19911990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 21 descendants4 generations forward: 22 descendants, 1 with a Class I recall15 generations forward: 18 descendants6 generations forward: 14 descendants7 generations forward: 21 descendants8 generations forward: 18 descendants9 generations forward: 16 descendants10 generations forward: 15 descendants11 generations forward: 6 descendants12 generations forward: 1 descendant K904993 · Laparoscopic Electrosurgical Device · Everest Medical Corp. · 19910+5+10
  1. Root · 1 generation backK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
  2. This deviceK031080 Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons…Gyrus Medical, Inc. · 2003
  3. Descendant · cites it directly · 154 of its ownK061260 Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 &…Intuitive Surgical, Inc. · 2006 · Recalled
  4. Descendant · 2 generations on · 153 of its ownK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
  5. Descendant · 3 generations on · 148 of its ownK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
  6. Descendant · 3 generations on · 124 of its ownK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
  7. Descendant · 4 generations on · 87 of its ownK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled

Showing 5 of 155 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12011: 12012: 12014: 52015: 22016: 72017: 72018: 92019: 52020: 122021: 122022: 132023: 172024: 182025: 262026: 18
2006high 26 (2025) · low 0 (2007)2026

Class I recalls in this family

  • K223095 Senhance Surgical System4 generations on · 2023

Most influential descendants

Showing 5 of 155 · See all
  • K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc. · 2006 · cites it directly154descendants
  • K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc. · 2009 · 2 generations on153descendants
  • K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · 3 generations on148descendants
  • K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · 3 generations on124descendants
  • K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · 4 generations on87descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904993Laparoscopic Electrosurgical DeviceEverest Medical Corp.1991—
0 (this device)K031080Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting…Gyrus Medical, Inc.2003—
+1K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.20061
+2K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200…Intuitive Surgical, Inc.20093
+3K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20122
+3K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201480
+4K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20142

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201110
201210
201450
201520
201670
201770
201890
201950
2020120
2021120
2022130
2023171
2024180
2025260
2026180
FIG. 1 — Lineage of K031080, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

1 device in this family has 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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K904993Laparoscopic Electrosurgical Device
Summary page 1
…Bipolar LYONS Dissecting Forceps The device is a Class II medical device. The Bipolar LYONS Dissecting Forceps is a modification to the predicate device cleared under K904993. The bipolar LYONS Dissecting Forceps is identical in construction (with the exception of shaft length) and in component material…
Everest Medical Corp.1991—

Also cleared against K904993: 11 other devices →

What descends from it? (155)

See all 155

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.2006154

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 24, 2013Class IIZ-1983-2013Packaging process controlOn April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated…

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.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K061260 (Intuitive Surgical, Inc., 2006) has gone furthest, with 154 descendants of its own.
  • 11 other devices also cite its predicate K904993.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

Electrosurgical coagulation, mechanical grasping and dissection of tissue during the performance of laparoscopic and general surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K904993

11 other devices cite the same predicate.

  • K030578Bipolar Grasper and Bipolar Scissors for the Zeus Microwrist Surgical SystemComputer Motion, Inc. · 2003
  • K031082Everest Bipolar L Hook & PK Bipolar L HookGyrus Medical, Inc. · 2003
  • K031081Everest LP Bipolar Scissors and Gyrus LP Bipolar ScissorsGyrus Medical, Inc. · 20031 recall
  • K031079Everest Bipolar Needle Electrode & Gyrus Bipolar Needle ElectrodeGyrus Medical, Inc. · 2003
  • K031078Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro, Micro & Molly ForcepsGyrus Medical, Inc. · 20031 recall
  • K030512Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 20031 recall

More from Gyrus Medical, Inc.

15 FDA decisions under this applicant name. See the company

  • K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
  • K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc. · 2005
  • K041999Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc. · 2005
  • K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc. · 2004
  • K024286Gyrus Open ForcepsGyrus Medical, Inc. · 20036 recalls

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K031080 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031080: Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031080

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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