510(k) · Cleared

Cleared

Gyrus Plasmakinetic Superpulse System (Generator, Accessories)

K031085510(k) TraditionalCleared Jul 21, 2003108-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

Gyrus Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 21, 2003 as substantially equivalent to K003060 (Everest Medical Corp., 2000) and 2 other predicates after a 108-day review. Its family tree reaches back 1 generation to 2000. 57 later devices descend from it.

Decided: Jul 21, 2003
Review: 108 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K001270 (2000). 3 ancestors in all. 57 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK001270 Gyrus Endourology System: Axipolar Resectoscope Loop ElectrodeGyrus Medical, Ltd. · 2000
This deviceK031085 Gyrus Plasmakinetic Superpulse System (Generator, Accessories)Gyrus Medical, Inc. · 2003
Descendant · cites it directly · 23 of its ownK082054 Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and…Gyrus Acmi, Inc. · 2008
Descendant · cites it directly · 22 of its ownK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
Descendant · 2 generations on · 16 of its ownK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
Descendant · cites it directly · 15 of its ownK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
Descendant · cites it directly · 14 of its ownK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2004high 5 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 57 · See all

K082054Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual Footswitch…Gyrus Acmi, Inc. · 2008 · cites it directly23descendants
K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010 · cites it directly22descendants
K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011 · 2 generations on16descendants
K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH · 2010 · cites it directly15descendants
K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005 · cites it directly14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001270	Gyrus Endourology System: Axipolar Resectoscope Loop Electrode	Gyrus Medical, Ltd.	2000	—
0 (this device)	K031085	Gyrus Plasmakinetic Superpulse System (Generator, Accessories)	Gyrus Medical, Inc.	2003	—
+1	K082054	Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual…	Gyrus Acmi, Inc.	2008	—
+1	K100816	PK Superpulse Sysem Generator Model 744000	Gyrus Acmi, Inc.	2010	—
+2	K110268	Forcetriad Electrosurgical Generator	Covidien Lp, Formerly Know AS Valleylab, A Divison	2011	—
+1	K100275	Working Element, Resection Button Electrode for Plasma Vaporizaton…	Olympus Winter & Ibe GmbH	2010	1
+1	K050550	Gyrus General Purpose Electrosurgical Generator	Gyrus Medical, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2008	4	0
2009	1	0
2010	4	0
2011	3	0
2012	4	0
2013	2	0
2014	1	0
2015	4	0
2016	4	0
2017	5	0
2018	3	0
2019	1	0
2021	3	0
2022	4	0
2023	4	0
2024	4	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K031085, 2000–2026Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K003060	Plasmakinetic Generator Summary page 1 …Brand Name: Not yet assigned Predicate Devices: Gyrus Inc PlasmaKinetic Generator (K003060) Gyrus Medical Ltd PlasmaKinetic Endourolcigy Generator…	Everest Medical Corp.	2000	—
*	K003569	Plasmakinetic Endourology System Summary page 1 …c Generator (K003060) Gyrus Medical Ltd PlasmaKinetic Endourolcigy Generator (K003569) Gyrus Medical Ltd Endourology Axipolar Resectoscope…	Gyrus Medical, Ltd.	2000	—
*	K001270	Gyrus Endourology System: Axipolar Resectoscope Loop Electrode Summary page 1 …(K003569) Gyrus Medical Ltd Endourology Axipolar Resectoscope Electrode (K001270) Gyrus Inc, Maple Grove, M N 5 10(k) Prexnarket Notification March 28, 2003…	Gyrus Medical, Ltd.	2000	—

Also cleared against K003060: 1 other device →

What descends from it? (57)

See all 57

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

Number	Device	Applicant	Decided	Descendants
K082054	Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual Footswitch…	Gyrus Acmi, Inc.	2008	23
K100816	PK Superpulse Sysem Generator Model 744000	Gyrus Acmi, Inc.	2010	22
K100275	Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…	Olympus Winter & Ibe GmbH	2010	15
K050550	Gyrus General Purpose Electrosurgical Generator	Gyrus Medical, Inc.	2005	14
K093181	Gyrus Acmi PK Button Electrode	Gyrus Acmi, Inc.	2010	4
K033027	Shinmed Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300	Shining World Health Care Co., Ltd.	2004	2
K121977	Plasmajet Neutral Plasma Surgery System	Plasma Surgical Limited	2012	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?

None of the 3 ancestors has a recall.
Of its descendants, K082054 (Gyrus Acmi, Inc., 2008) has gone furthest, with 23 descendants of its own.
1 other device also cites its predicate K003060.

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 Gyrus PlasmaKinetic Superpulse System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031085 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031085: Gyrus Plasmakinetic Superpulse System (Generator, Accessories).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031085

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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