510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

E-Z Clean Laparoscopic Electrode

K913281510(k) TraditionalCleared Aug 16, 199123-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

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

Cleared on Aug 16, 1991 after a 23-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 18 later devices descend from it. It has been recalled once.

Decided
Aug 16, 1991
Review
23 days
Class
Class II
Product code
GEI
Recalls
1
Predicates
0

18 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2004: 1 descendant cleared2014: 2 descendants cleared2016: 1 descendant cleared2006: 2 descendants cleared2019: 2 descendants cleared2023: 3 descendants cleared2008: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK913281 E-Z Clean Laparoscopic ElectrodeMegadyne Medical Products, Inc. · 1991
  2. Descendant · cites it directly · 11 of its ownK040699 Laparoscopic Electrode, Reusable Indicator Shaft (Leris)Megadyne Medical Products, Inc. · 2004
  3. Descendant · 2 generations on · 8 of its ownK052759 Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · Recalled
  4. Descendant · 3 generations on · 7 of its ownK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
  5. Descendant · 4 generations on · 6 of its ownK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
  6. Descendant · cites it directly · 3 of its ownK153265 New Deantronics Disposable Laparoscopic Electrodes, non-coated, and…New Deantronics Taiwan, Ltd. · 2016

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

1999: 12004: 12006: 22008: 12011: 12012: 12014: 22015: 12016: 12019: 22023: 32024: 12026: 1
1999high 3 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 18 · See all
  • K040699Laparoscopic Electrode, Reusable Indicator Shaft (Leris)Megadyne Medical Products, Inc. · 2004 · cites it directly11descendants
  • K052759Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · 2 generations on8descendants
  • K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008 · 3 generations on7descendants
  • K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011 · 4 generations on6descendants
  • K153265New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coatedNew Deantronics Taiwan, Ltd. · 2016 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913281E-Z Clean Laparoscopic ElectrodeMegadyne Medical Products, Inc.1991—
+1K040699Laparoscopic Electrode, Reusable Indicator Shaft (Leris)Megadyne Medical Products, Inc.2004—
+2K052759Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG20061
+3K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc.2008—
+4K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc.2011—
+1K153265New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coatedNew Deantronics Taiwan, Ltd.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200410
200620
200810
201110
201210
201420
201510
201610
201920
202330
202410
202610
FIG. 1 — Lineage of K913281, 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K040699Laparoscopic Electrode, Reusable Indicator Shaft (Leris)Megadyne Medical Products, Inc.200411
K153265New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coatedNew Deantronics Taiwan, Ltd.20163
K134006Disposable Laparoscopic Electrode, Disposable Laparoscopic ElectrodeModern Medical Equipment Manufacturing Limited20140
K984239Slicktip Solid Laparoscopic Electrode, Models LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z…Aaron Medical Industries19990

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 7, 2013Class IIZ-2097-2013Process controlMegadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K040699 (Megadyne Medical Products, Inc., 2004) has gone furthest, with 11 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—

More from Megadyne Medical Products, Inc.

50 FDA decisions under this applicant name. See the company

  • K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad -…Megadyne Medical Products, Inc. · 20243 Class I recalls
  • K213696ETHICON Megadyne Electrosurgical GeneratorMegadyne Medical Products, Inc. · 2022
  • 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/K913281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913281: E-Z Clean Laparoscopic Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913281

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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