# K051749: Cobra Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Estech, Inc.
- Decided: Sep 13, 2005 after 76 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 2 generations back to K012459 (2001). 4 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981981: Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt) Model 4811, Instrument Cable, 19, Boston Scientific Corp (1998) Summary page 2.
- K041599: Cobra Adhere Surgical System, Estech, Inc. (2004) Summary page 2.
- K040812: Detect Surgical Pacing and Mapping Tool, Medtronic Vascular (2004) Summary page 2.

## Most influential descendants
- K061593: Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 (2006), 13 descendants of its own
- K100501: Multifunctional Linear Pen (2010), 9 descendants of its own
- K113475: Estech Cobra Adhere XL 2 Surgical System (2012), 4 descendants of its own
- K130521: Isolator Linear Pen (2013), 3 descendants of its own
- K163408: Isolator Multifunctional Linear Pen (2017), 2 descendants of its own

## 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/K051749
Methodology: https://510kreport.com/methodology