510(k) Report

510(k) · Cleared

Cleared

Cobra Cardiac Electrosurgical System

K013873510(k) TraditionalCleared Jul 11, 2002232-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 Jul 11, 2002 as substantially equivalent to K013392 (Medtronic Vascular, 2002) and 2 other predicates after a 232-day review. Its family tree reaches back 2 generations to 1992. 61 later devices descend from it.

Decided
Jul 11, 2002
Review
232 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K921884 (1992). 7 ancestors in all, the oldest K870705 (1987). 61 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 4 other ancestors1987: 1 other ancestor2004: 4 descendants cleared2007: 2 descendants cleared2006: 5 descendants cleared2003: 1 descendant cleared2008: 5 descendants cleared2005: 1 descendant cleared2011: 3 descendants cleared2010: 3 descendants cleared2012: 5 descendants cleared2009: 3 descendants cleared2019: 4 descendants cleared2018: 4 descendants cleared2021: 2 descendants cleared2022: 2 descendants cleared2014: 5 descendants cleared2013: 2 descendants cleared2020: 2 descendants cleared2025: 2 descendants cleared2024: 3 descendants cleared2016: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant clearedK921884 · FORCE 2 · Valleylab, Inc. · 1992K013392 · Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880 · Medtronic Vascular · 2002 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 6 descendants2 generations forward: 9 descendants3 generations forward: 16 descendants4 generations forward: 12 descendants5 generations forward: 9 descendants6 generations forward: 6 descendants7 generations forward: 3 descendants K013392 · Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880 · Medtronic Vascular · 2002 · recalledK921884 · FORCE 2 · Valleylab, Inc. · 19920+5
  1. Root · 2 generations backK921884 FORCE 2Valleylab, Inc. · 1992
  2. 1 generation backK013392 Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate…Medtronic Vascular · 2002 · Recalled
  3. This deviceK013873 Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002
  4. Descendant · cites it directly · 46 of its ownK023288 Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003
  5. Descendant · 2 generations on · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
  6. Descendant · cites it directly · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
  7. Descendant · 2 generations on · 22 of its ownK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
  8. Descendant · cites it directly · 22 of its ownK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2003: 12004: 42005: 12006: 52007: 22008: 52009: 32010: 32011: 32012: 52013: 22014: 52016: 12018: 42019: 42020: 22021: 22022: 22023: 12024: 32025: 22026: 1
2003high 5 (2006) · low 0 (2015)2026

Most influential descendants

Showing 5 of 61 · See all
  • K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003 · cites it directly46descendants
  • K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · 2 generations on42descendants
  • K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · cites it directly23descendants
  • K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc. · 2006 · 2 generations on22descendants
  • K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc. · 2004 · cites it directly22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K921884FORCE 2Valleylab, Inc.1992—
−1K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular20021
0 (this device)K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp2002—
+1K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies2003—
+2K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2004—
+1K022894Epicor Medical Ablation SystemEpicor Medical, Inc.2004—
+2K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and…Cryocath Technologies, Inc.20061
+1K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9…Epicor Medical, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
200140

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200440
200510
200650
200720
200850
200930
201030
201130
201250
201320
201450
201610
201840
201940
202020
202120
202220
202310
202430
202520
202610
FIG. 1 — Lineage of K013873, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (3)

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
*K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…
Cleared while this submission was under review
Medtronic Vascular20021
*K003978Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N…Afx, Inc.2001—
*K870705Thermal Coagulator
Summary page 1
…2. AFx Microwave Flex Ablation Wand System, KO03978 Predicate Device 3, Wedge Surgical System K870705 1. Medtronic 2, AFx Predicate Device Manufacturer(6)…
Microvasive1987—

Also cleared against K013392: 11 other devices →

What descends from it? (61)

See all 61

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

NumberDeviceApplicantDecidedDescendants
K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies200346
K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423
K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422
K043579Atricure Bipolar SystemAtriCure, Inc.200718
K053326Estech Cobra Electrosurgical Unit & CableEndoscopic Technologies, Inc.20067
K040219Cobra Surgical ProbeBoston Scientific Corp20040

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 10 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K023288 (Boston Scientific EP Technologies, 2003) has gone furthest, with 46 descendants of its own.
  • 11 other devices also cite its predicate K013392.

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 Cobra® 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.

Also cleared against K013392

11 other devices cite the same predicate.

  • K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical…Medtronic, Inc. · 2008
  • K073605Atricure Coolrail Linear PenAtriCure, Inc. · 2008
  • K043579Atricure Bipolar SystemAtriCure, Inc. · 2007
  • K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular · 2007
  • K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc. · 2006
  • K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 20061 recall

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https://510kreport.com/device/K013873 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013873: Cobra Cardiac Electrosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013873

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026