# K203795: Star RF Electrode, VIVA RF Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Starmed Co., Ltd.
- Decided: Apr 1, 2021 after 94 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K252833: VIVA combo RF System (2026), 0 descendants of its own

## Indications for use
Star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

Source page: https://510kreport.com/device/K203795
Methodology: https://510kreport.com/methodology