510(k) · Cleared

Cleared

Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600

K993265510(k) SpecialCleared Oct 22, 199923-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

Soring GmbH Medizintechnik · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 22, 1999 as substantially equivalent to K954171 (Holl Meditronics, Inc., 1996) after a 23-day review. Its family tree reaches back 1 generation to 1996. 28 later devices descend from it.

Decided: Oct 22, 1999
Review: 23 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954171 (1996). 28 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
This deviceK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
Descendant · cites it directly · 26 of its ownK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
Descendant · 2 generations on · 24 of its ownK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
Descendant · 3 generations on · 7 of its ownK063639 Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
Descendant · 3 generations on · 5 of its ownK111732 Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011
Descendant · 3 generations on · 4 of its ownK132974 Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini…Medtronic Advanced Energy, LLC · 2013

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2003high 3 (2011) · low 0 (2004)2026

Most influential descendants

Showing 5 of 28 · See all

K024059MBC SeriesSoring GmbH Medizintechnik · 2003 · cites it directly26descendants
K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · 2 generations on24descendants
K063639Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007 · 3 generations on7descendants
K111732Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011 · 3 generations on5descendants
K132974Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein…Medtronic Advanced Energy, LLC · 2013 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954171	Arco-MBC, Arco MC	Holl Meditronics, Inc.	1996	—
0 (this device)	K993265	Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600	Soring GmbH Medizintechnik	1999	—
+1	K024059	MBC Series	Soring GmbH Medizintechnik	2003	—
+2	K052859	Aquamantys Pump Generator System	Tissuelink Medical, Inc.	2005	1
+3	K063639	Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1	Tissuelink Medical, Inc.	2007	—
+3	K111732	Aquamantys SBS 5.0 Sheated Biopolar Sealer	Salient Surgical Technologies, Inc.	2011	—
+3	K132974	Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4…	Medtronic Advanced Energy, LLC	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2005	1	0
2007	1	0
2008	1	0
2010	2	0
2011	3	0
2012	2	0
2013	3	0
2014	1	0
2017	2	0
2019	2	0
2020	1	0
2021	2	0
2022	2	0
2023	3	0

FIG. 1 — Lineage of K993265, 1996–2023Source: 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? (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
*	K954171	Arco-MBC, Arco MC Summary page 1 …MBC 601, MBC 600 Common name: Electrosurgical conductive gas coagulation Classification name: General Surgery Predicate Device: Applicant: Soéring GmbH 510(k) Number: K954171 Device: ARCO MBC, ARCO MC, MBC 500 Device Description: ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 are amtspgtaded version…	Holl Meditronics, Inc.	1996	—

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K024059	MBC Series	Soring GmbH Medizintechnik	2003	26
K030028	CPC by Soring GMBH	Soring GmbH Medizintechnik	2003	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?

Its one ancestor has no recall.
Of its descendants, K024059 (Soring GmbH Medizintechnik, 2003) has gone furthest, with 26 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	—

What is it indicated for?

The devices are intended to cut and or coagulate (soft) biological tissue with gas enhanced coagulation in ARCO models, e.g. during general surgical procedures.

Typical users of this system are trained medical professionals.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993265 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993265: Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993265

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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