# K222997: VVR Generator system

- Pathway: 510(k) (Traditional)
- Applicant: Starmed Co., Ltd.
- Decided: Oct 25, 2023 after 392 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: 10 generations back to K943450 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 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 5.
- K111887: Closurefast Radiofrequency Catheter, Covidien (2011) Summary page 5.

## Indications for use
VVR Generator system is intended for endovascular coagulation of Saphenous Veins in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K222997
Methodology: https://510kreport.com/methodology