# K131949: Aem Disposable Suction Irrigation Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Encision, Inc.
- Decided: Aug 26, 2013 after 60 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 K934094 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100711: Suction Irrigation Electrodes and Adapters, Encision, Inc. (2010) Summary page 1.
- K122580: Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction Irrigation Electrodes Model ES077X Series, Encision, Inc. (2012) Summary page 1.

## Indications for use
Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions 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/K131949
Methodology: https://510kreport.com/methodology