510(k) · Cleared

Cleared

Valleylab G3000 Electrosurgical Instrument

K051627510(k) TraditionalCleared Jul 22, 200532-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

Valleylab · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 22, 2005 as substantially equivalent to K813071 (Valleylab, Inc., 1981) and 1 other predicate after a 32-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.

Decided: Jul 22, 2005
Review: 32 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K813071 (1981). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK813071 E2508 Disposable Handswitching PencilValleylab, Inc. · 1981
This deviceK051627 Valleylab G3000 Electrosurgical InstrumentValleylab · 2005
Descendant · cites it directly · 0 of its ownK150735 Force TriVerse Electrosugical Device, Holster, 10-foot, Force…Covidien · 2015 · Recalled
Descendant · cites it directly · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006

Most influential descendants

Showing 2 of 2 · See all

K150735Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical…Covidien · 2015 · cites it directly0descendants
K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K813071	E2508 Disposable Handswitching Pencil	Valleylab, Inc.	1981	—
0 (this device)	K051627	Valleylab G3000 Electrosurgical Instrument	Valleylab	2005	—
+1	K150735	Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse…	Covidien	2015	2
+1	K052692	Suretek Medical Reprocessed Electrosurgical Electrodes	Suretek Medical	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2015	1	0

FIG. 1 — Lineage of K051627, 1981–2015Source: 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
*	K813071	E2508 Disposable Handswitching Pencil Summary page 1 …ery 3. Predicate Devices The G3000 Electrosurgical Device is substantially equivalent in function and intended use to the Valleylab E2516 Electrosurgical Pencil (K813071) and the Valleylab E2517 Power Control Pencil (K861112). All three devices are used for monopolar electrosurgery, allowing…	Valleylab, Inc.	1981	—
*	K861112	Model E2517 and Model E2503 Power Control Pencils Summary page 1 …vice is substantially equivalent in function and intended use to the Valleylab E2516 Electrosurgical Pencil (K813071) and the Valleylab E2517 Power Control Pencil (K861112). All three devices are used for monopolar electrosurgery, allowing the surgeon to actuate the electrosurgical generator fr…	Valleylab, Inc.	1986	—

Also cleared against K813071: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K150735	Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical…	Covidien	2015	0
K052692	Suretek Medical Reprocessed Electrosurgical Electrodes	Suretek Medical	2006	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K150735 (Covidien, 2015) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K813071.

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 Valleylab G3000 Electrosurgical Device is a single-use device intended for use in open surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The G3000 Electrosurgical Device is intended for use with the Valleylab ForceTriad T Electrosurgical Generator and conventional monopolar electrosurgical elbctrodes, such as blade, needle, ball, LLETZ loop, and arthroscopic electrodes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051627: Valleylab G3000 Electrosurgical Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051627

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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