510(k) · Cleared

Cleared

Cobra Cooled Cardiac Surgical Probe, Model 1596X

K023291510(k) SpecialCleared Oct 17, 200215-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

Boston Scientific Corp · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 17, 2002 as substantially equivalent to K981981 (Boston Scientific Corp, 1998) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1998. 25 later devices descend from it.

Decided: Oct 17, 2002
Review: 15 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K981981 (1998). 2 ancestors in all. 25 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK981981 Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical…Boston Scientific Corp · 1998
This deviceK023291 Cobra Cooled Cardiac Surgical Probe, Model 1596XBoston Scientific Corp · 2002
Descendant · cites it directly · 22 of its ownK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
Descendant · 2 generations on · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
Descendant · 3 generations on · 10 of its ownK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
Descendant · 3 generations on · 6 of its ownK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
Descendant · 3 generations on · 5 of its ownK110117 Atricure Bipolar SystemAtriCure, Inc. · 2011

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2003high 3 (2008) · low 0 (2005)2026

Most influential descendants

Showing 5 of 25 · See all

K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc. · 2004 · cites it directly22descendants
K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · 2 generations on18descendants
K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc. · 2008 · 3 generations on10descendants
K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc. · 2010 · 3 generations on6descendants
K110117Atricure Bipolar SystemAtriCure, Inc. · 2011 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K981981	Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu)…	Boston Scientific Corp	1998	—
0 (this device)	K023291	Cobra Cooled Cardiac Surgical Probe, Model 1596X	Boston Scientific Corp	2002	—
+1	K040641	Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9…	Epicor Medical, Inc.	2004	—
+2	K043579	Atricure Bipolar System	AtriCure, Inc.	2007	—
+3	K080509	Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation…	Medtronic, Inc.	2008	—
+3	K101174	Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model…	AtriCure, Inc.	2010	—
+3	K110117	Atricure Bipolar System	AtriCure, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2006	1	0
2007	1	0
2008	3	0
2009	1	0
2010	2	0
2011	1	0
2012	2	0
2018	1	0
2019	2	0
2020	1	0
2021	2	0
2022	2	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K023291, 1998–2025Source: 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? (2)

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
*	K981981	Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt)… Summary page 2 …issue to produce hemostasis. Comparison to Predicate Device: Predicate Device Modified Device 51Nk’l Reference K981981; KO10956 Current Submission Intended Use Coagulation of tissue Same Device…	Boston Scientific Corp	1998	—
*	K010956	Cobra 1/2 Flex Surgical Probe, Model 1593X; Cobra Flex Surgical Probe Model 1594X	Boston Scientific Corp	2001	—

Also cleared against K981981: 4 other devices →

What descends from it? (25)

See all 25

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

Number	Device	Applicant	Decided	Descendants
K040641	Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…	Epicor Medical, Inc.	2004	22
K032207	Cobra Cooled Surgical Probe, Model M004159670	Boston Scientific Corp	2003	1

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?

None of the 2 ancestors has a recall.
Of its descendants, K040641 (Epicor Medical, Inc., 2004) has gone furthest, with 22 descendants of its own.
4 other devices also cite its predicate K981981.

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 CobraB Cardiac Surgical Probe (Probe) is intended for the

coagulation of cardiac tissue using radiofrequency (RF) energy

during cardiac surgery. The Probe can be used during general

surgery to coagulate soft tissues. The Probe 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/K023291 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023291: Cobra Cooled Cardiac Surgical Probe, Model 1596X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023291

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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