510(k) · Cleared

Cleared

Erbotom Icc 300

K953738510(k) TraditionalCleared Oct 16, 199567-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 Electromedizin GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 16, 1995 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided: Oct 16, 1995
Review: 67 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

16 later devices descend from it, 2 citing it directly.

This deviceK953738 Erbotom Icc 300Erbe Electromedizin GmbH · 1995
Descendant · cites it directly · 14 of its ownK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
Descendant · 2 generations on · 13 of its ownK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
Descendant · 3 generations on · 12 of its ownK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
Descendant · 3 generations on · 7 of its ownK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
Descendant · 4 generations on · 1 of its ownK243120 HybridAPC probeErbe Elektromedizin GmbH · 2025

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2002high 3 (2020) · low 0 (2003)2026

Most influential descendants

Showing 5 of 16 · See all

K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007 · cites it directly14descendants
K083608Erbe Hybrid KnifeErbe USA, Inc. · 2009 · 2 generations on13descendants
K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015 · 3 generations on12descendants
K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · 3 generations on7descendants
K243120HybridAPC probeErbe Elektromedizin GmbH · 2025 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K953738	Erbotom Icc 300	Erbe Electromedizin GmbH	1995	—
+1	K062712	Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094	Erbe USA, Inc.	2007	—
+2	K083608	Erbe Hybrid Knife	Erbe USA, Inc.	2009	—
+3	K143306	ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe	Erbe USA, Inc.	2015	—
+3	K171158	Single Use Electrosurgical knife	Olympus Medical Systems Corp.	2017	2
+4	K243120	HybridAPC probe	Erbe Elektromedizin GmbH	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2007	1	0
2009	1	0
2015	1	0
2017	1	0
2019	1	0
2020	3	0
2021	1	0
2022	1	0
2023	2	0
2025	3	0

FIG. 1 — Lineage of K953738, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
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, K062712 (Erbe USA, Inc., 2007) has gone furthest, with 14 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/K953738 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953738: Erbotom Icc 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953738

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026