510(k) · Cleared
ClearedEstech Cobra Bipolar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endoscopic Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 19, 2005 as substantially equivalent to K023288 (Boston Scientific EP Technologies, 2003) after a 46-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- Dec 19, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921884 (1992). 9 ancestors in all, the oldest K870705 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK921884 FORCE 2Valleylab, Inc. · 1992
- 3 generations backK013392 Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate…Medtronic Vascular · 2002 · Recalled
- 2 generations backK013873 Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002
- 1 generation backK023288 Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003
- This deviceK053100 Estech Cobra Bipolar SystemEndoscopic Technologies, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK100224 Estech Cobra Bipolsr IIEndoscopic Technologies, Inc. D/B/A Estech · 2010
- Descendant · 2 generations on · 0 of its ownK133017 Estech Cobra (R) Genesis Bipolar ClampEstech, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921884 | FORCE 2 | Valleylab, Inc. | 1992 | — |
| −3 | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation… | Medtronic Vascular | 2002 | 1 |
| −2 | K013873 | Cobra Cardiac Electrosurgical System | Boston Scientific Corp | 2002 | — |
| −1 | K023288 | Cobra Bipolar Clamp, Model 15902 | Boston Scientific EP Technologies | 2003 | — |
| 0 (this device) | K053100 | Estech Cobra Bipolar System | Endoscopic Technologies, Inc. | 2005 | — |
| +1 | K100224 | Estech Cobra Bipolsr II | Endoscopic Technologies, Inc. D/B/A Estech | 2010 | — |
| +2 | K133017 | Estech Cobra (R) Genesis Bipolar Clamp | Estech, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2001 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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? (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 | Decided |
|---|---|---|---|
| * | K023288 | Cobra Bipolar Clamp, Model 15902Summary page 2…data is not necessary to support this submission since the Estech Cobra Bipolar System is identical to the predicate device, the Boston Scientific Cobra Bipolar System (K023288). CONFIDENTIAL DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100224 | Estech Cobra Bipolsr II | 2010 | 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?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K100224 (Endoscopic Technologies, Inc. D/B/A Estech, 2010) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K023288.
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 Bipolar System is intended for the coagulation of soft tissue during general surgery. 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/K053100 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053100: Estech Cobra Bipolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053100
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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