510(k) Report

510(k) · Cleared

Cleared

Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode

K031079510(k) SpecialCleared May 21, 200347-day reviewClass II21 CFR 878.4400

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 21, 2003 as substantially equivalent to K904993 (Everest Medical Corp., 1991) after a 47-day review. Its family tree reaches back 1 generation to 1991. 35 later devices descend from it.

Decided
May 21, 2003
Review
47 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K904993 (1991). 35 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 5 descendants cleared2004: 1 descendant cleared2008: 2 descendants cleared2011: 2 descendants cleared2012: 2 descendants cleared2022: 2 descendants cleared2016: 3 descendants cleared2025: 3 descendants cleared2013: 1 descendant cleared2017: 3 descendants cleared2021: 1 descendant cleared2018: 2 descendants cleared2023: 1 descendant cleared2026: 2 descendants cleared2020: 2 descendants cleared2024: 3 descendants clearedK904993 · Laparoscopic Electrosurgical Device · Everest Medical Corp. · 19911990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 9 descendants4 generations forward: 8 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants K904993 · Laparoscopic Electrosurgical Device · Everest Medical Corp. · 19910+5
  1. Root · 1 generation backK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
  2. This deviceK031079 Everest Bipolar Needle Electrode & Gyrus Bipolar Needle ElectrodeGyrus Medical, Inc. · 2003
  3. Descendant · cites it directly · 24 of its ownK081129 Enseal…Surgrx, Inc. · 2008
  4. Descendant · 2 generations on · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
  5. Descendant · 2 generations on · 11 of its ownK101990 Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011
  6. Descendant · 3 generations on · 9 of its ownK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014
  7. Descendant · 3 generations on · 9 of its ownK132703 ThunderbeatOlympus Medical Systems Corp. · 2014

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2004: 12008: 22011: 22012: 22013: 12014: 52016: 32017: 32018: 22020: 22021: 12022: 22023: 12024: 32025: 32026: 2
2004high 5 (2014) · low 0 (2005)2026

Most influential descendants

Showing 5 of 35 · See all
  • K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc. · 2008 · cites it directly24descendants
  • K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · 2 generations on11descendants
  • K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011 · 2 generations on11descendants
  • K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014 · 3 generations on9descendants
  • K132703ThunderbeatOlympus Medical Systems Corp. · 2014 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904993Laparoscopic Electrosurgical DeviceEverest Medical Corp.1991—
0 (this device)K031079Everest Bipolar Needle Electrode & Gyrus Bipolar Needle ElectrodeGyrus Medical, Inc.2003—
+1K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc.2008—
+2K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.201210
+2K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC2011—
+3K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC2014—
+3K132703ThunderbeatOlympus Medical Systems Corp.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200820
201120
201220
201310
201450
201630
201730
201820
202020
202110
202220
202310
202430
202530
202620
FIG. 1 — Lineage of K031079, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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. #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 Needle Electrode The device is a Class II medical device. The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993. The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when…
Everest Medical Corp.1991—

Also cleared against K904993: 11 other devices →

What descends from it? (35)

See all 35

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc.200824
K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048
K142154PK NeedleGyrus Acmi, Inc.20141

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?

  • Its one ancestor has no recall.
  • Of its descendants, K081129 (Surgrx, Inc., 2008) has gone furthest, with 24 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 cutting and mechanical 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
  • K031081Everest LP Bipolar Scissors and Gyrus LP Bipolar ScissorsGyrus Medical, Inc. · 20031 recall
  • K031082Everest Bipolar L Hook & PK Bipolar L HookGyrus Medical, Inc. · 2003
  • K031078Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro, Micro & Molly ForcepsGyrus Medical, Inc. · 20031 recall
  • K031080Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting 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/K031079 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031079: Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031079

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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