# K140006: Endoshield Burn Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Encision, Inc.
- Decided: Jun 16, 2014 after 165 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 K913625 (1991). 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)
- K122383: EM3 Aem Monitor Aem Connectors, Encision, Inc. (2013) Summary page 1.

## Indications for use
The EndoShield Burn Protection System is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. EndoShield performs active electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the shaft of the instument.

Source page: https://510kreport.com/device/K140006
Methodology: https://510kreport.com/methodology