# K040104: Cobra Adhere Surgical System, Model M00415977C0

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Feb 18, 2004 after 29 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: 3 generations back to K981981 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032207: Cobra Cooled Surgical Probe, Model M004159670, Boston Scientific Corp (2003) Summary page 1.

## Indications for use
The intended use for Cobra Adhere Surgical System is as follows: The Cobra Adhere Surgical System (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/K040104
Methodology: https://510kreport.com/methodology