# K113475: Estech Cobra Adhere XL 2 Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Endoscopic Technologies, Inc. D/B/A Estech
- Decided: Mar 20, 2012 after 119 days
- Product code: OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K942299 (1995). 49 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051749: Cobra Surgical System, Estech, Inc. (2005)
- K100501: Multifunctional Linear Pen, AtriCure, Inc. (2010) Summary page 1.

## Most influential descendants
- K120857: Epi-Sense Guided Coagulation Device with Visitrax (2012), 2 descendants of its own
- K142084: Epi-Sense Guided Coagulation Device with Visitrax (2014), 1 descendant of its own
- K193162: EPi-Sense Guided Coagulation System with VisiTrax (2019), 0 descendants of its own
- K190151: COBRA Fusion Ablation System (2019), 0 descendants of its own

## Recalls of this device
- Jan 22, 2019 · Class II · Z-0830-2019: 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: 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: 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: 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: 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 st

## Indications for use
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.

Source page: https://510kreport.com/device/K113475
Methodology: https://510kreport.com/methodology