# K252833: VIVA combo RF System

- Pathway: 510(k) (Traditional)
- Applicant: Starmed Co., Ltd.
- Decided: May 26, 2026 after 263 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: 8 generations back to K870028 (1987). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234140: VIVA combo RF System (VIVA combo RF System), Starmed Co., Ltd. (2024) Summary page 5.
- K203795: Star RF Electrode, VIVA RF Electrode, Starmed Co., Ltd. (2021) Summary page 5.

## Indications for use
The VIVA combo RF generator, star RF Electrodes, and VIVA RF Electrodes are indicated for percutaneous and interoperative coagulation and ablation of tissue, including ultrasound-guided percutaneous ablation of cytologically-confirmed benign thyroid nodules in adults that are symptomatic, cosmetically concerning, and/or autonomously functioning. Autonomously functioning nodules are indicated if nodule volume is < 10 mL.

Source page: https://510kreport.com/device/K252833
Methodology: https://510kreport.com/methodology