510(k) · Cleared

Cleared

Slicktip Solid Laparoscopic Electrode, Models LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07Z

K984239510(k) TraditionalCleared Feb 10, 199975-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

Aaron Medical Industries · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 10, 1999 as substantially equivalent to K971621 (Aaron Medical Industries, 1997) and 3 other predicates after a 75-day review. Its family tree reaches back 1 generation to 1990.

Decided: Feb 10, 1999
Review: 75 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K904560 (1990). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK904560 Valleylab Laparoscopic Handswitch/ElectrodesValleylab, Inc. · 1990
This deviceK984239 Slicktip Solid Laparoscopic Electrode, Models LH01Z, LB02Z, LN03Z…Aaron Medical Industries · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904560	Valleylab Laparoscopic Handswitch/Electrodes	Valleylab, Inc.	1990	—
0 (this device)	K984239	Slicktip Solid Laparoscopic Electrode, Models LH01Z, LB02Z, LN03Z, LC04Z…	Aaron Medical Industries	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1994	1	0
1997	1	0

FIG. 1 — Lineage of K984239, 1990–1999Source: 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? (5)

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
*	K971621	Resistick Solid Laparoscopic Electrodes Summary page 1 …single use. The Aaron SlickTip Solid Laparoscopic Electrode is IDENTICAL to the Resistick Solid Laparoscopic Electrodes by Aaron Medical Industries, Inc, cleared under K971621 dated June 20, 1997 with the coating cleared under K974735. It is substantially equivalent to the MegaDyne K913281, the Valleylab…	Aaron Medical Industries	1997	—
*	K913281	E-Z Clean Laparoscopic Electrode Summary page 1 …trodes by Aaron Medical Industries, Inc, cleared under K971621 dated June 20, 1997 with the coating cleared under K974735. It is substantially equivalent to the MegaDyne K913281, the Valleylab K904560, the Conmed K942892 and the WJ Surgical Hi-Tip Laparoscopic electrodes in design, operation, intended use…	Megadyne Medical Products, Inc.	1991	1
*	K904560	Valleylab Laparoscopic Handswitch/Electrodes Summary page 1 …Industries, Inc, cleared under K971621 dated June 20, 1997 with the coating cleared under K974735. It is substantially equivalent to the MegaDyne K913281, the Valleylab K904560, the Conmed K942892 and the WJ Surgical Hi-Tip Laparoscopic electrodes in design, operation, intended use, materials, components…	Valleylab, Inc.	1990	—
*	K942892	Conmed Select-One Laparoscopic Electrosurgical Blade Summary page 1 …ared under K971621 dated June 20, 1997 with the coating cleared under K974735. It is substantially equivalent to the MegaDyne K913281, the Valleylab K904560, the Conmed K942892 and the WJ Surgical Hi-Tip Laparoscopic electrodes in design, operation, intended use, materials, components and performance clai…	Conmedcorp	1994	—
*	—	WJ Surgical Hi-Tip Laparoscopic electrodes Named without a submission number			—
†	K974735	Standard and Extended Blade, Needle and Ball; Modified Standard and Extended Blade &…	Aaron Medical Industries	1998	—

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 4 ancestors has a recall of any class.

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 Subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K984239 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984239: Slicktip Solid Laparoscopic Electrode, Models LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07Z.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984239

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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