# K053100: Estech Cobra Bipolar System

- Pathway: 510(k) (Traditional)
- Applicant: Endoscopic Technologies, Inc.
- Decided: Dec 19, 2005 after 46 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: 4 generations back to K921884 (1992). 9 ancestors in all.
2 later devices descend 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)
- K023288: Cobra Bipolar Clamp, Model 15902, Boston Scientific EP Technologies (2003) Summary page 2.

## Most influential descendants
- K100224: Estech Cobra Bipolsr II (2010), 1 descendant of its own
- K133017: Estech Cobra (R) Genesis Bipolar Clamp (2013), 0 descendants of its own

## Indications for use
The ESTECH Cobra Bipolar 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/K053100
Methodology: https://510kreport.com/methodology