510(k) · Cleared
ClearedCobra Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Estech, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 13, 2005 as substantially equivalent to K981981 (Boston Scientific Corp, 1998) and 2 other predicates after a 76-day review. Its family tree reaches back 2 generations to 2001. 19 later devices descend from it.
- Decided
- Sep 13, 2005
- Review
- 76 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K012459 (2001). 4 ancestors in all, the oldest K981981 (1998). 19 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK012459 Model 6494 Unipolar Temporary Myocardial Pacing WireMedtronic Vascular · 2001
- 1 generation backK040812 Detect Surgical Pacing and Mapping ToolMedtronic Vascular · 2004
- This deviceK051749 Cobra Surgical SystemEstech, Inc. · 2005
- Descendant · cites it directly · 13 of its ownK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 9 of its ownK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · Recalled
- Descendant · 3 generations on · 3 of its ownK130521 Isolator Linear PenAtriCure, Inc. · 2013
- Descendant · 4 generations on · 2 of its ownK163408 Isolator Multifunctional Linear PenAtriCure, Inc. · 2017
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc. · 2006 · cites it directly13descendants
- K100501Multifunctional Linear PenAtriCure, Inc. · 2010 · 2 generations on9descendants
- K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · cites it directly4descendants
- K130521Isolator Linear PenAtriCure, Inc. · 2013 · 3 generations on3descendants
- K163408Isolator Multifunctional Linear PenAtriCure, Inc. · 2017 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012459 | Model 6494 Unipolar Temporary Myocardial Pacing Wire | Medtronic Vascular | 2001 | — |
| −1 | K040812 | Detect Surgical Pacing and Mapping Tool | Medtronic Vascular | 2004 | — |
| 0 (this device) | K051749 | Cobra Surgical System | Estech, Inc. | 2005 | — |
| +1 | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 | AtriCure, Inc. | 2006 | 1 |
| +2 | K100501 | Multifunctional Linear Pen | AtriCure, Inc. | 2010 | — |
| +1 | K113475 | Estech Cobra Adhere XL 2 Surgical System | Endoscopic Technologies, Inc. D/B/A Estech | 2012 | 5 |
| +3 | K130521 | Isolator Linear Pen | AtriCure, Inc. | 2013 | — |
| +4 | K163408 | Isolator Multifunctional Linear Pen | AtriCure, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 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 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981981 | Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt)…Summary page 2…l SystemTM Device Classification: 21 CFR 878.4400 Predicate Device Information: Predicate Devices: Electrosurgical Probe (K981981) Cobra Adhere Surgical System (K041599) Det… | 1998 |
| * | K041599 | Cobra Adhere Surgical SystemSummary page 2…e Device Information: Predicate Devices: Electrosurgical Probe (K981981) Cobra Adhere Surgical System (K041599) Detect Mapping and Pacing Tool (K040812) Predicate Device Manufacturers: B… | 2004 |
| * | K040812 | Detect Surgical Pacing and Mapping ToolSummary page 2…be (K981981) Cobra Adhere Surgical System (K041599) Detect Mapping and Pacing Tool (K040812) Predicate Device Manufacturers: Boston Scientific Corporation Endoscopic T… | 2004 |
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 | 2006 | 13 |
| K113475 | Estech Cobra Adhere XL 2 Surgical System | 2012 | 4 |
| K150134 | Basic, Dominant Flex, KV-6 | 2015 | 2 |
| K110913 | Estech Cobra Surgical System with Thermashield Accessory | 2011 | 0 |
| K061544 | Stellartech 100 Coagulation System | 2006 | 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 4 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K061593 (AtriCure, Inc., 2006) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K981981.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 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 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/K051749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051749: Cobra Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051749
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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