# K191612: Encision AEM Monopolar Laparoscopic Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Encision Incorporated
- Decided: Mar 20, 2020 after 277 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: 1 generation back to K912780 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912780: Monopolar Laparoscopic Electrodes W/Eletroshield, Electroscope, Inc. (1991) Summary page 4.
- K091074: Aem Disposable Electrodes,Model ESO300 Series, Encision, Inc. (2009) Summary page 4.

## Most influential descendants
- K201018: Encision AEM enTouch 2X Scissor (2020), 0 descendants of its own

## 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/K191612
Methodology: https://510kreport.com/methodology