510(k) · Cleared

Cleared

MBC Series

K024059510(k) SpecialCleared Jan 8, 200330-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 Jan 8, 2003 as substantially equivalent to K993265 (Soring GmbH Medizintechnik, 1999) after a 30-day review. Its family tree reaches back 2 generations to 1996. 26 later devices descend from it.

Decided: Jan 8, 2003
Review: 30 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K954171 (1996). 26 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
1 generation backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
This deviceK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
Descendant · cites it directly · 24 of its ownK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
Descendant · 2 generations on · 7 of its ownK063639 Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
Descendant · 2 generations on · 5 of its ownK111732 Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK132974 Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini…Medtronic Advanced Energy, LLC · 2013
Descendant · 2 generations on · 4 of its ownK130110 Meddusa Bipolar SystemElliquence, LLC · 2013

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2005high 3 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 26 · See all

K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · cites it directly24descendants
K063639Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007 · 2 generations on7descendants
K111732Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011 · 2 generations on5descendants
K132974Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein…Medtronic Advanced Energy, LLC · 2013 · 2 generations on4descendants
K130110Meddusa Bipolar SystemElliquence, LLC · 2013 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K954171	Arco-MBC, Arco MC	Holl Meditronics, Inc.	1996	—
−1	K993265	Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600	Soring GmbH Medizintechnik	1999	—
0 (this device)	K024059	MBC Series	Soring GmbH Medizintechnik	2003	—
+1	K052859	Aquamantys Pump Generator System	Tissuelink Medical, Inc.	2005	1
+2	K063639	Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1	Tissuelink Medical, Inc.	2007	—
+2	K111732	Aquamantys SBS 5.0 Sheated Biopolar Sealer	Salient Surgical Technologies, Inc.	2011	—
+2	K132974	Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4…	Medtronic Advanced Energy, LLC	2013	—
+2	K130110	Meddusa Bipolar System	Elliquence, LLC	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K024059, 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
*	K993265	Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 Summary page 1 …ce: Name: Soring GmbH, ARCO 3000, ARCO 2000, ARCO 1000, and MBC Series 51O(k) Number K993265 Regulation Nurn ber 878.4400 - Device, Electrosurgical, Cutting & Coagulation &…	Soring GmbH Medizintechnik	1999	—

Also cleared against K993265: 1 other device →

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K052859	Aquamantys Pump Generator System	Tissuelink Medical, Inc.	2005	24
K093511	Soring MBC200/BCC140	Soring GmbH Medizintechnik	2010	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?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K052859 (Tissuelink Medical, Inc., 2005) has gone furthest, with 24 descendants of its own.
1 other device also cites its predicate K993265.

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 during surgical procedures.

Typical users of this system are trained medical professionals.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024059 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024059: MBC Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024059

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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