510(k) · Cleared

Cleared

Laparoscopic Electrode, Reusable Indicator Shaft (Leris)

K040699510(k) TraditionalCleared Jun 4, 200479-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

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

Cleared on Jun 4, 2004 as substantially equivalent to K913281 (Megadyne Medical Products, Inc., 1991) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 1991. 11 later devices descend from it.

Decided: Jun 4, 2004
Review: 79 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K913281 (1991). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK913281 E-Z Clean Laparoscopic ElectrodeMegadyne Medical Products, Inc. · 1991 · Recalled
This deviceK040699 Laparoscopic Electrode, Reusable Indicator Shaft (Leris)Megadyne Medical Products, Inc. · 2004
Descendant · cites it directly · 8 of its ownK052759 Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · Recalled
Descendant · 2 generations on · 7 of its ownK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
Descendant · 3 generations on · 6 of its ownK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
Descendant · 4 generations on · 1 of its ownK142208 Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
Descendant · cites it directly · 1 of its ownK060232 Trokamed GMBH Electrosurgical Instruments & AccessoriesTrokamed GmbH · 2006 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 11 · See all

K052759Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · cites it directly8descendants
K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008 · 2 generations on7descendants
K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011 · 3 generations on6descendants
K142208Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015 · 4 generations on1descendant
K060232Trokamed GMBH Electrosurgical Instruments & AccessoriesTrokamed GmbH · 2006 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913281	E-Z Clean Laparoscopic Electrode	Megadyne Medical Products, Inc.	1991	1
0 (this device)	K040699	Laparoscopic Electrode, Reusable Indicator Shaft (Leris)	Megadyne Medical Products, Inc.	2004	—
+1	K052759	Dan Monopolar Lap Accessories	Dannoritzer Medizintechnik GmbH & Co. KG	2006	1
+2	K081503	Aed Monopolar Lap Accessories	National Advanced Endoscopy Devices, Inc.	2008	—
+3	K103508	Unmiax Laparoscopic Instrument	Unimax Medical Systems, Inc.	2011	—
+4	K142208	Monopolar Laparascopic Accessories	Unimicro Medical Systems (Shenzhen) Co., Ltd.	2015	—
+1	K060232	Trokamed GMBH Electrosurgical Instruments & Accessories	Trokamed GmbH	2006	10

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2008	1	0
2011	1	0
2012	1	0
2014	1	0
2015	1	0
2019	1	0
2023	2	0
2026	1	0

FIG. 1 — Lineage of K040699, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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What was it cleared against? (2)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K913281	E-Z Clean Laparoscopic Electrode Summary page 2 …coagulation device and accessories D. PredicateDevices Megadyne's E-Z Clean Laparoscopic Electrode, cleared for marketing via 510(k) #(K913281) and, ElectrosurgicalCutting and CoagulationDevice, cleared for marketing via 5 10(k) #K943055. E. Applicant Device Descr…	Megadyne Medical Products, Inc.	1991	1
*	K943055	Electrosurgical Cutting and Coagulating Device and Accessories Summary page 2 …Clean Laparoscopic Electrode, cleared for marketing via 510(k) #(K913281) and, ElectrosurgicalCutting and CoagulationDevice, cleared for marketing via 5 10(k) #K943055. E. Applicant Device Description The Reusable Uncoated Laparoscopic Electrodes are stainless steel electrosurgical e…	Megadyne Medical Products, Inc.	1994	2

Also cleared against K913281: 3 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K052759	Dan Monopolar Lap Accessories	Dannoritzer Medizintechnik GmbH & Co. KG	2006	8
K060232	Trokamed GMBH Electrosurgical Instruments & Accessories	Trokamed GmbH	2006	1

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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K052759 (Dannoritzer Medizintechnik GmbH & Co. KG, 2006) has gone furthest, with 8 descendants of its own.
3 other devices also cite its predicate K913281.

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

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

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

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

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	—

What is it indicated for?

The Reusable Laparoscopic Electrodes are intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.

The electrodes are reusable; they are intended to be cleaned, sterilized, and reused.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040699 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040699: Laparoscopic Electrode, Reusable Indicator Shaft (Leris).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040699

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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