510(k) · Cleared

Cleared

Erbotom Icc 350

K933002510(k) TraditionalCleared Mar 9, 1994261-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

Erbe USA, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 9, 1994 after a 261-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 160 later devices descend from it.

Decided: Mar 9, 1994
Review: 261 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

160 later devices descend from it, 4 citing it directly.

This deviceK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
Descendant · cites it directly · 136 of its ownK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
Descendant · 2 generations on · 115 of its ownK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
Descendant · 2 generations on · 55 of its ownK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
Descendant · cites it directly · 52 of its ownK990628 Gyrus Endourology SystemGyrus Medical, Ltd. · 1999
Descendant · 2 generations on · 49 of its ownK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled

Showing 5 of 160 descendants. See all descendants

Descendants cleared per year

1999high 15 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 160 · See all

K023886Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002 · cites it directly136descendants
K060484Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006 · 2 generations on115descendants
K083452Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008 · 2 generations on55descendants
K990628Gyrus Endourology SystemGyrus Medical, Ltd. · 1999 · cites it directly52descendants
K030194Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · 2 generations on49descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K933002	Erbotom Icc 350	Erbe USA, Inc.	1994	—
+1	K023886	Erbe Vio Esu with Accessories, Model Vio 300 D	Erbe USA, Inc.	2002	—
+2	K060484	Erbe Vio Esu, Model Vio 300 D	Erbe USA, Inc.	2006	—
+2	K083452	Erbe Model Vio 300 D with Accessories	Erbe USA, Inc.	2008	—
+1	K990628	Gyrus Endourology System	Gyrus Medical, Ltd.	1999	—
+2	K030194	Xues-41 Endoscopic Electrosurgical Unit	The Olympus Optical Co.	2003	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0
2002	2	0
2003	1	0
2005	1	0
2006	2	0
2007	2	0
2008	4	0
2009	1	0
2010	5	0
2011	5	0
2012	5	0
2013	3	0
2014	5	0
2015	4	0
2016	7	0
2017	14	0
2018	8	0
2019	14	0
2020	8	0
2021	10	0
2022	15	0
2023	15	0
2024	11	0
2025	12	0
2026	4	0

FIG. 1 — Lineage of K933002, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (160)

See all 160

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

Number	Device	Applicant	Decided	Descendants
K023886	Erbe Vio Esu with Accessories, Model Vio 300 D	Erbe USA, Inc.	2002	136
K990628	Gyrus Endourology System	Gyrus Medical, Ltd.	1999	52
K062712	Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094	Erbe USA, Inc.	2007	14
K014172	Nelson Electrosurgical Unit, Model GN640	Aesculap, Inc.	2002	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?

Of its descendants, K023886 (Erbe USA, Inc., 2002) has gone furthest, with 136 descendants of its own.

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	—

https://510kreport.com/device/K933002 · printed Nov 4, 2026

Cite this page

510(k) Report. “K933002: Erbotom Icc 350.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933002

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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