# K041599: Cobra Adhere Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Estech, Inc.
- Decided: Jul 27, 2004 after 43 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
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cobra Adhere Surgical System: named in the summary without a submission number

## Most influential descendants
- K051749: Cobra Surgical System (2005), 19 descendants of its own
- 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
- K063012: Ncontact Coagulation System Kit, Model CSK (2006), 6 descendants of its own
- K113475: Estech Cobra Adhere XL 2 Surgical System (2012), 4 descendants of its own

## Indications for use
The Estech Cobra Adhere 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/K041599
Methodology: https://510kreport.com/methodology