# K110913: Estech Cobra Surgical System with Thermashield Accessory

- Pathway: 510(k) (Special)
- Applicant: Endoscopic Technologies, Inc. D/B/A Estech
- Decided: Sep 23, 2011 after 175 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: 3 generations back to K012459 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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)

## Indications for use
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.

Source page: https://510kreport.com/device/K110913
Methodology: https://510kreport.com/methodology