510(k) · Cleared

Cleared

Ues-30 Electrosurgical Unit and It's Associated Accessories

K023767510(k) SpecialCleared Nov 29, 200217-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

The Olympus Optical Co. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 29, 2002 as substantially equivalent to K970184 (Olympus America, Inc., 1997) after a 17-day review. Its family tree reaches back 2 generations to 1991. 50 later devices descend from it.

Decided: Nov 29, 2002
Review: 17 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K911904 (1991). 50 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
1 generation backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
This deviceK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
Descendant · cites it directly · 49 of its ownK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
Descendant · 2 generations on · 22 of its ownK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
Descendant · 3 generations on · 16 of its ownK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
Descendant · 2 generations on · 15 of its ownK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
Descendant · 2 generations on · 12 of its ownK103032 Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W…Olympus Winter & Ibe GmbH · 2011

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2003high 6 (2021) · low 0 (2004)2026

Most influential descendants

Showing 5 of 50 · See all

K030194Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · cites it directly49descendants
K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010 · 2 generations on22descendants
K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011 · 3 generations on16descendants
K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH · 2010 · 2 generations on15descendants
K103032Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal…Olympus Winter & Ibe GmbH · 2011 · 2 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K911904	Models Ues-10 & PSD-10	Olympus Corp.	1991	—
−1	K970184	Olympus Ues-20 Electrosurgical System and Its Associated Accessories	Olympus America, Inc.	1997	—
0 (this device)	K023767	Ues-30 Electrosurgical Unit and It's Associated Accessories	The Olympus Optical Co.	2002	—
+1	K030194	Xues-41 Endoscopic Electrosurgical Unit	The Olympus Optical Co.	2003	3
+2	K100816	PK Superpulse Sysem Generator Model 744000	Gyrus Acmi, Inc.	2010	—
+3	K110268	Forcetriad Electrosurgical Generator	Covidien Lp, Formerly Know AS Valleylab, A Divison	2011	—
+2	K100275	Working Element, Resection Button Electrode for Plasma Vaporizaton…	Olympus Winter & Ibe GmbH	2010	1
+2	K103032	Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch…	Olympus Winter & Ibe GmbH	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2010	2	0
2011	3	0
2012	2	0
2013	1	0
2014	1	0
2015	3	0
2016	3	0
2017	4	0
2018	4	0
2019	1	0
2021	6	0
2022	4	0
2023	5	0
2024	4	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K023767, 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? (1)

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
*	K970184	Olympus Ues-20 Electrosurgical System and Its Associated Accessories Summary page 1 …2 1 CFR 878.4400 Electrosurgical cutting and coagulation device and accessories, Class II Predicate Device: UES-20 (#K970184) D. Description of the Device(s) This instrument has been designed for general and endoscopic electrosurgery in…	Olympus America, Inc.	1997	—

Also cleared against K970184: 3 other devices →

What descends from it? (50)

See all 50

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030194	Xues-41 Endoscopic Electrosurgical Unit	The Olympus Optical Co.	2003	49

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?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K030194 (The Olympus Optical Co., 2003) has gone furthest, with 49 descendants of its own.
3 other devices also cite its predicate K970184.

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?

This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source and ancillary equipment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023767 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023767: Ues-30 Electrosurgical Unit and It's Associated Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023767

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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