# K981430: Union Medical UM-D30 Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: She Medical, Inc.
- Decided: Jun 5, 1998 after 46 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 UM-D30 Coagulator is used in small surgica) procedures in dermatology, plastic surgery and genersl surgery in order to gnly coagulate {burn) an open wound or skin lesions. This device doe; not cut the skin, it only closes open wounds or lesions by coagulating (burning) the skin in any of the small surgical procedures meationed above. Federal Law restricts the use of this device by or on the order of a qualified physician only.

Source page: https://510kreport.com/device/K981430
Methodology: https://510kreport.com/methodology