# K240758: Radiofrequency Generator System, Cura RF Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Curaway Medical Technology Co., Ltd.
- Decided: Dec 11, 2024 after 266 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: 7 generations back to K870028 (1987). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163450: VIVA combo RF System, Starmed Co., Ltd. (2017) Summary page 5.
- K172012: star RF Electrode, VIVA RF Electrode, Starmed Co., Ltd. (2018) Summary page 5.

## Indications for use
Radiofrequency Generator System is used in conjunction with Cura RF Electrode for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures. The Cura RF Electrode is to be used with Radiofrequency Generator System intended for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

Source page: https://510kreport.com/device/K240758
Methodology: https://510kreport.com/methodology