# K981416: Magnatek Electrosurgical Units Models, Esu-10, Esu-15

- Pathway: 510(k) (Traditional)
- Applicant: Magna Advanced Technologies, Inc.
- Decided: Jun 24, 1998 after 65 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 ESU-10 / ESU-15 units is to be used in order to cut and coagulate (burn) the skin in surgical procedures. Federal Law restricts the use of this device by or on the order of a qualified physician only.

Source page: https://510kreport.com/device/K981416
Methodology: https://510kreport.com/methodology