# K180999: Mygen V-1000 RF System

- Pathway: 510(k) (Traditional)
- Applicant: RF Medical Co., Ltd.
- Decided: Dec 11, 2018 after 239 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K193355: Electrodes Handpieces for Mygen V-1000 RF System (2020), 1 descendant of its own
- K232763: Electrode Handpieces (VCT, RFTV, BMDT series) (2023), 0 descendants of its own
- K221277: Mygen M-3004 RF Generator M-3004 (2022), 0 descendants of its own

## Indications for use
The Mygen V-1000 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

Source page: https://510kreport.com/device/K180999
Methodology: https://510kreport.com/methodology