# K122580: Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction Irrigation Electrodes Model ES077X Series

- Pathway: 510(k) (Traditional)
- Applicant: Encision, Inc.
- Decided: Nov 9, 2012 after 78 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 K973890 (1998). 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)
- K973890: Universalplus Laparoscopic Abc/Electrosurgical Electrode, Conmedcorp (1998) Summary page 1.
- K091074: Aem Disposable Electrodes,Model ESO300 Series, Encision, Inc. (2009) Summary page 1.

## Most influential descendants
- K131949: Aem Disposable Suction Irrigation Electrodes (2013), 0 descendants of its own

## Indications for use
Sterile, single-patient-use electrosurgical accessory initended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation fuinctions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures. AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.

Source page: https://510kreport.com/device/K122580
Methodology: https://510kreport.com/methodology