510(k) Report

510(k) · Cleared

Cleared

Estech Cobra Electrosurgical Unit & Cable

K053326510(k) TraditionalCleared Jan 6, 200636-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

Endoscopic Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jan 6, 2006 as substantially equivalent to K013873 (Boston Scientific Corp, 2002) after a 36-day review. Its family tree reaches back 3 generations to 1992. 7 later devices descend from it.

Decided
Jan 6, 2006
Review
36 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K921884 (1992). 8 ancestors in all, the oldest K870705 (1987). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 4 other ancestors1987: 1 other ancestor2006: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant clearedK921884 · FORCE 2 · Valleylab, Inc. · 1992K013392 · Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880 · Medtronic Vascular · 2002 · recalledK013873 · Cobra Cardiac Electrosurgical System · Boston Scientific Corp · 20021990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K013873 · Cobra Cardiac Electrosurgical System · Boston Scientific Corp · 2002K013392 · Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880 · Medtronic Vascular · 2002 · recalledK921884 · FORCE 2 · Valleylab, Inc. · 19920+5
  1. Root · 3 generations backK921884 FORCE 2Valleylab, Inc. · 1992
  2. 2 generations backK013392 Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate…Medtronic Vascular · 2002 · Recalled
  3. 1 generation backK013873 Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002
  4. This deviceK053326 Estech Cobra Electrosurgical Unit & CableEndoscopic Technologies, Inc. · 2006
  5. Descendant · cites it directly · 6 of its ownK063012 Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc. · 2006
  6. Descendant · 2 generations on · 4 of its ownK082203 Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022…Ncontact Surgical, Inc. · 2008
  7. Descendant · 2 generations on · 4 of its ownK071819 Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and…Ncontact Surgical, Inc. · 2007
  8. Descendant · 3 generations on · 3 of its ownK090202 Numeris Guided Coagulation System with Visitrax, Models CSK-121…Ncontact Surgical, Inc. · 2009
  9. Descendant · 4 generations on · 2 of its ownK120857 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 12009: 12012: 12014: 12019: 1
2006high 1 (2006) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all
  • K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc. · 2006 · cites it directly6descendants
  • K082203Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025Ncontact Surgical, Inc. · 2008 · 2 generations on4descendants
  • K071819Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515Ncontact Surgical, Inc. · 2007 · 2 generations on4descendants
  • K090202Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125Ncontact Surgical, Inc. · 2009 · 3 generations on3descendants
  • K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K921884FORCE 2Valleylab, Inc.1992—
−2K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular20021
−1K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp2002—
0 (this device)K053326Estech Cobra Electrosurgical Unit & CableEndoscopic Technologies, Inc.2006—
+1K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc.2006—
+2K082203Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023…Ncontact Surgical, Inc.2008—
+2K071819Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515Ncontact Surgical, Inc.2007—
+3K090202Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123…Ncontact Surgical, Inc.2009—
+4K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
200140

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200810
200910
201210
201410
201910
FIG. 1 — Lineage of K053326, 1992–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K013873Cobra Cardiac Electrosurgical System
Summary page 2
…gical Unit is identical in intended use, technology, design, materials, manufacture, and packaging to that of the Boston Scientific Cobra Cardiac Electrosurgical System (K013873). The Instrument/Cobra Cables arc accessories to their respective FSU's. They, too, are identical to each other. Estech conclude…
Boston Scientific Corp2002—

Also cleared against K013873: 5 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc.20066

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 14 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K063012 (Ncontact Surgical, Inc., 2006) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K013873.

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

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
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

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Estech Cobra Cardiac Electrosurgical 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 tissue. The System may also be used to

coagulate blood and soft tissue to produce hemostasis.

Indications for use as stated in the FDA summary.

Also cleared against K013873

5 other devices cite the same predicate.

  • K043579Atricure Bipolar SystemAtriCure, Inc. · 2007
  • K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14…Epicor Medical, Inc. · 2004
  • K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
  • K040219Cobra Surgical ProbeBoston Scientific Corp · 2004
  • K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003

More from Endoscopic Technologies, Inc.

8 FDA decisions under this applicant name. See the company

  • K060101Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006
  • K053100Estech Cobra Bipolar SystemEndoscopic Technologies, Inc. · 2005
  • K946105Electrosurgical Cutting & Coagulation Device & AccessoriesEndoscopic Technologies, Inc. · 1995
  • K945978Tubing, NoninvasiveEndoscopic Technologies, Inc. · 1995
  • K945979Trocar/CannulaEndoscopic Technologies, Inc. · 1994

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The GEI category page

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https://510kreport.com/device/K053326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053326: Estech Cobra Electrosurgical Unit & Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053326

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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