# K100224: Estech Cobra Bipolsr II

- Pathway: 510(k) (Traditional)
- Applicant: Endoscopic Technologies, Inc. D/B/A Estech
- Decided: Apr 7, 2010 after 71 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: 5 generations back to K921884 (1992). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053100: Estech Cobra Bipolar System, Endoscopic Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K133017: Estech Cobra (R) Genesis Bipolar Clamp (2013), 0 descendants of its own

## Indications for use
The ESTECH Cobra Bipolar II System is intended for the coagulation of soft tissue during general surgery. The system may also be used to coagulate blood and soft tissue to produce hemostasis.

Source page: https://510kreport.com/device/K100224
Methodology: https://510kreport.com/methodology