# K221277: Mygen M-3004 RF Generator M-3004

- Pathway: 510(k) (Traditional)
- Applicant: RF Medical Co., Ltd.
- Decided: Sep 2, 2022 after 122 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: 1 generation back to K180999 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180999: Mygen V-1000 RF System, RF Medical Co., Ltd. (2018) Summary page 4.

## Indications for use
The Mygen M-3004 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

Source page: https://510kreport.com/device/K221277
Methodology: https://510kreport.com/methodology