# K133017: Estech Cobra (R) Genesis Bipolar Clamp

- Pathway: 510(k) (Special)
- Applicant: Estech, Inc.
- Decided: Oct 7, 2013 after 11 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: 6 generations back to K921884 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100224: Estech Cobra Bipolsr II, Endoscopic Technologies, Inc. D/B/A Estech (2010) Summary page 1.

## Indications for use
The Estech COBRA® Genesis Bipolar Clamp 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/K133017
Methodology: https://510kreport.com/methodology