510(k) · Cleared
ClearedEstech Cobra Surgical System with Thermashield Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endoscopic Technologies, Inc. D/B/A Estech · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on Sep 23, 2011 as substantially equivalent to K051749 (Estech, Inc., 2005) after a 175-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Sep 23, 2011
- Review
- 175 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K012459 (2001). 5 ancestors in all, the oldest K981981 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK012459 Model 6494 Unipolar Temporary Myocardial Pacing WireMedtronic Vascular · 2001
- 2 generations backK040812 Detect Surgical Pacing and Mapping ToolMedtronic Vascular · 2004
- 1 generation backK051749 Cobra Surgical SystemEstech, Inc. · 2005
- This deviceK110913 Estech Cobra Surgical System with Thermashield AccessoryEndoscopic Technologies, Inc. D/B/A Estech · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012459 | Model 6494 Unipolar Temporary Myocardial Pacing Wire | Medtronic Vascular | 2001 | — |
| −2 | K040812 | Detect Surgical Pacing and Mapping Tool | Medtronic Vascular | 2004 | — |
| −1 | K051749 | Cobra Surgical System | Estech, Inc. | 2005 | — |
| 0 (this device) | K110913 | Estech Cobra Surgical System with Thermashield Accessory | Endoscopic Technologies, Inc. D/B/A Estech | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 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 OCL? 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 OCL device
- #1 K252056 Isolator® Synergy™ EnCompass Clamp and Guide…score 13.0 · 12 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 |
|---|---|---|---|
| * | K051749 | Cobra Surgical System | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 3.1 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K051749.
How does its category compare?
All OCL devicesOCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OCL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCL
85in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCL
46in 2025
MAUDE reports naming product code OCL, 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 | 3 | 139 | 0 | 0 |
| 2008 | 5 | 81 | 1 | 0 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 2 | — | 2 | 23 |
| 2011 | 2 | — | 0 | 21 |
| 2012 | 6 | 75 | 0 | 21 |
| 2013 | 2 | — | 1 | 13 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 31 |
| 2016 | 0 | — | 1 | 76 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 2 | — | 0 | 61 |
| 2019 | 6 | 85 | 4 | 49 |
| 2020 | 1 | — | 4 | 37 |
| 2021 | 2 | — | 1 | 63 |
| 2022 | 2 | — | 0 | 59 |
| 2023 | 0 | — | 0 | 99 |
| 2024 | 1 | — | 0 | 59 |
| 2025 | 1 | — | 0 | 46 |
| 2026 | 0 | — | 0 | — |
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110913: Estech Cobra Surgical System with Thermashield Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110913
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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