# K232505: Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Curaway Medical Technology Co., Ltd.
- Decided: May 30, 2024 after 286 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: 9 generations back to K943450 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040638: Vnus Radiofrequency Generator, Model RFG2, Vnus Medical Technologies, Inc. (2004) Summary page 4.
- K061373: Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100, Vnus Medical Technologies, Inc. (2006) Summary page 4.

## Indications for use
The JM-S40 Endovenous Radiofrequency Generator is intended for use with CuraWay’s Endovenous RF Catheter intended for vessel and tissue coagulation. The Endovenous Radiofrequency Catheter is intended to be used with CuraWay’s JM-S40 Endovenous RF Generator indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K232505
Methodology: https://510kreport.com/methodology