510(k) Report

510(k) · Cleared

Recalled · 2002

Electrosurgical Cutting and Coagulating Device and Accessories

K943055510(k) TraditionalCleared Dec 21, 1994177-day reviewClass II21 CFR 878.4400Recalls 2

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

Megadyne Medical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 21, 1994 after a 177-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 later devices descend from it. It has been recalled 2 times.

Decided
Dec 21, 1994
Review
177 days
Class
Class II
Product code
GEI
Recalls
2
Predicates
0

38 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2008: 3 descendants cleared2006: 2 descendants cleared2026: 2 descendants cleared2012: 2 descendants cleared2014: 5 descendants cleared2010: 3 descendants cleared2016: 2 descendants cleared2015: 3 descendants cleared2018: 1 descendant cleared2011: 1 descendant cleared2017: 1 descendant cleared2020: 3 descendants cleared2019: 2 descendants cleared2023: 2 descendants cleared2022: 3 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK943055 Electrosurgical Cutting and Coagulating Device and AccessoriesMegadyne Medical Products, Inc. · 1994
  2. Descendant · cites it directly · 25 of its ownK073616 Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008
  3. Descendant · 2 generations on · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
  4. Descendant · cites it directly · 11 of its ownK040699 Laparoscopic Electrode, Reusable Indicator Shaft (Leris)Megadyne Medical Products, Inc. · 2004
  5. Descendant · 3 generations on · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
  6. Descendant · 2 generations on · 8 of its ownK052759 Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · Recalled

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22008: 32010: 32011: 12012: 22014: 52015: 32016: 22017: 12018: 12019: 22020: 32022: 32023: 22024: 12025: 12026: 2
2004high 5 (2014) · low 0 (2005)2026

Most influential descendants

Showing 5 of 38 · See all
  • K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008 · cites it directly25descendants
  • K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · 2 generations on24descendants
  • K040699Laparoscopic Electrode, Reusable Indicator Shaft (Leris)Megadyne Medical Products, Inc. · 2004 · cites it directly11descendants
  • K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · 3 generations on8descendants
  • K052759Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943055Electrosurgical Cutting and Coagulating Device and AccessoriesMegadyne Medical Products, Inc.1994—
+1K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd.2008—
+2K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection…Peak Surgical, Inc.20081
+1K040699Laparoscopic Electrode, Reusable Indicator Shaft (Leris)Megadyne Medical Products, Inc.2004—
+3K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.2010—
+2K052759Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200830
201030
201110
201220
201450
201530
201620
201710
201810
201920
202030
202230
202320
202410
202510
202620
FIG. 1 — Lineage of K943055, 1994–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (38)

See all 38

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

NumberDeviceApplicantDecidedDescendants
K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd.200825
K040699Laparoscopic Electrode, Reusable Indicator Shaft (Leris)Megadyne Medical Products, Inc.200411

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 20, 2002Not classifiedZ-0468-03OtherThe metal substrate cautery tip may break during use.
Dec 20, 2002Not classifiedZ-0469-03OtherThe metal substrate cautery tip may break during use.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K073616 (Electromedics Co., Ltd., 2008) has gone furthest, with 25 descendants of its own.

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—

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50 FDA decisions under this applicant name. See the company

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  • K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m…Megadyne Medical Products, Inc. · 2020
  • K193145Ethicon Megadyne Electrosurgical Generator, Bipolar FootswitchMegadyne Medical Products, Inc. · 2020
  • K191328Megadyne Foot SwitchMegadyne Medical Products, Inc. · 2019

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https://510kreport.com/device/K943055 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943055: Electrosurgical Cutting and Coagulating Device and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943055

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026