# K201018: Encision AEM enTouch 2X Scissor

- Pathway: 510(k) (Special)
- Applicant: Encision, Inc.
- Decided: Jul 15, 2020 after 89 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: 2 generations back to K912780 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191612: Encision AEM Monopolar Laparoscopic Instruments and Accessories, Encision Incorporated (2020) Summary page 4.

## Indications for use
These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. Scissors Inserts are intended for use on soft tissue only.

Source page: https://510kreport.com/device/K201018
Methodology: https://510kreport.com/methodology