# K974793: Elmed Esu 120 M/M Digital

- Pathway: 510(k) (Traditional)
- Applicant: Elmed, Inc.
- Decided: Mar 19, 1998 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EIMED ESU 120 M/M DIGITAL iS a electrosurgical system designed for surgical procedures to be chosen by licensed surgeons. The unit can be used for unipolar cutting, unipolar micro-coagulation and bipolar ocoagulation.

Source page: https://510kreport.com/device/K974793
Methodology: https://510kreport.com/methodology