510(k) · Cleared

Cleared

Cobra Adhere Surgical System

K041599510(k) TraditionalCleared Jul 27, 200443-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

Estech, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 27, 2004 after a 43-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.

Decided: Jul 27, 2004
Review: 43 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

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

This deviceK041599 Cobra Adhere Surgical SystemEstech, Inc. · 2004
Descendant · cites it directly · 19 of its ownK051749 Cobra Surgical SystemEstech, Inc. · 2005
Descendant · 2 generations on · 13 of its ownK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
Descendant · 3 generations on · 9 of its ownK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
Descendant · cites it directly · 6 of its ownK063012 Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc. · 2006
Descendant · 2 generations on · 4 of its ownK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2005high 3 (2006) · low 0 (2016)2026

Most influential descendants

Showing 5 of 24 · See all

K051749Cobra Surgical SystemEstech, Inc. · 2005 · cites it directly19descendants
K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc. · 2006 · 2 generations on13descendants
K100501Multifunctional Linear PenAtriCure, Inc. · 2010 · 3 generations on9descendants
K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc. · 2006 · cites it directly6descendants
K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K041599	Cobra Adhere Surgical System	Estech, Inc.	2004	—
+1	K051749	Cobra Surgical System	Estech, Inc.	2005	—
+2	K061593	Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1	AtriCure, Inc.	2006	1
+3	K100501	Multifunctional Linear Pen	AtriCure, Inc.	2010	—
+1	K063012	Ncontact Coagulation System Kit, Model CSK	Ncontact Surgical, Inc.	2006	—
+2	K113475	Estech Cobra Adhere XL 2 Surgical System	Endoscopic Technologies, Inc. D/B/A Estech	2012	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	3	0
2007	2	0
2008	1	0
2009	2	0
2010	1	0
2011	1	0
2012	3	0
2013	1	0
2014	1	0
2015	1	0
2017	3	0
2019	3	0
2022	1	0

FIG. 1 — Lineage of K041599, 2004–2022Source: 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
*	—	Cobra Adhere Surgical System Named without a submission number			—

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K051749	Cobra Surgical System	Estech, Inc.	2005	19
K063012	Ncontact Coagulation System Kit, Model CSK	Ncontact Surgical, Inc.	2006	6

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, K051749 (Estech, Inc., 2005) has gone furthest, with 19 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 Estech Cobra Adhere Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041599 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041599: Cobra Adhere Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041599

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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