510(k) · Cleared
Recalled · Class II · 2019Estech Cobra Adhere XL 2 Surgical System
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 Mar 20, 2012 as substantially equivalent to K051749 (Estech, Inc., 2005) and 1 other predicate after a 119-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 20, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 9 generations to K942299 (1995). 49 ancestors in all, the oldest K811390 (1981). 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 5 generations between
- 3 generations backK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · Recalled
- 2 generations backK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
- 1 generation backK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
- This deviceK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012
- Descendant · cites it directly · 2 of its ownK120857 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK142084 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK193162 EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK190151 COBRA Fusion Ablation SystemAtriCure, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 8 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 7 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 6 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 5 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 4 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 3 generations backK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · Recalled
- 2 generations backK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
- 1 generation backK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
- This deviceK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012
Most influential descendants
Showing 4 of 4 · See all- K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012 · cites it directly2descendants
- K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2014 · 2 generations on1descendant
- K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. · 2019 · 3 generations on0descendants
- K190151COBRA Fusion Ablation SystemAtriCure, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −8 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −7 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −6 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −5 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −4 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −3 | K050459 | Atricure Isolator Transpolar Pen | AtriCure, Inc. | 2005 | 1 |
| −2 | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 | AtriCure, Inc. | 2006 | 1 |
| −1 | K100501 | Multifunctional Linear Pen | AtriCure, Inc. | 2010 | — |
| 0 (this device) | K113475 | Estech Cobra Adhere XL 2 Surgical System | Endoscopic Technologies, Inc. D/B/A Estech | 2012 | — |
| +1 | K120857 | Epi-Sense Guided Coagulation Device with Visitrax | Ncontact Surgical, Inc. | 2012 | — |
| +2 | K142084 | Epi-Sense Guided Coagulation Device with Visitrax | Ncontact Surgical, Inc. | 2014 | 1 |
| +3 | K193162 | EPi-Sense Guided Coagulation System with VisiTrax | AtriCure, Inc. | 2019 | — |
| +1 | K190151 | COBRA Fusion Ablation System | AtriCure, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 8 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 2 | 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? (2)
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 |
| * | K100501 | Multifunctional Linear PenSummary page 1…dicate Device Classification Number: Class 11, OCL Predicate Device Information: Predicate Devices: Multifunctional Linear Pen (K100501) Predicate Device Manufacturers: AtriCure, Inc. Predicate Device Common Name: Surgical Devi… | 2010 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 22, 2019 | Class II | Z-0830-2019 | Unknown/Undetermined by firm | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized. |
| Jan 22, 2019 | Class II | Z-0829-2019 | Unknown/Undetermined by firm | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized. |
| Jan 22, 2019 | Class II | Z-0831-2019 | Unknown/Undetermined by firm | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized. |
| Jan 22, 2019 | Class II | Z-0832-2019 | Unknown/Undetermined by firm | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized. |
| Sep 22, 2016 | Class II | Z-0653-2017 | Component design/selection | Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 49 ancestors have a recall of any class.
- Of its descendants, K120857 (Ncontact Surgical, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 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. 2012, 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 Adhere XL2 is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical Unit (ESU).
The ESTECH Cobra Adhere XL 2 may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external pacemaker or recording device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113475: Estech Cobra Adhere XL 2 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/K113475
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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