# K981781: Electrosurgical Unit

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Med, Inc.
- Decided: Dec 4, 1998 after 198 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
HM-880DG Plus Electrocoagulator unit is to be used in order to cut and coagulate (burn) the skin in small surgical procedures such as in dermatology, plastic surgery and general surgery. Federal Law restricts the use of this device by or on the order of qualified physician only.

Source page: https://510kreport.com/device/K981781
Methodology: https://510kreport.com/methodology