# K190151: COBRA Fusion Ablation System

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Feb 25, 2019 after 26 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K942299 (1995). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113475: Estech Cobra Adhere XL 2 Surgical System, Endoscopic Technologies, Inc. D/B/A Estech (2012) Summary page 4.

## Indications for use
The COBRA Fusion® ablation system is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Electrosurgical unit (ESU). The COBRA Fusion Pacing/Recording Adapter Cable 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 cardiac pacemaker or recording device.

Source page: https://510kreport.com/device/K190151
Methodology: https://510kreport.com/methodology