# K163450: VIVA combo RF System

- Pathway: 510(k) (Traditional)
- Applicant: Starmed Co., Ltd.
- Decided: Mar 8, 2017 after 90 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: 5 generations back to K870028 (1987). 16 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042216: Cool-Tip RF Ablation System, Valleylab (2004) Summary page 5.

## Most influential descendants
- K183538: VIVA combo RF System (2019), 2 descendants of its own
- K240932: HybridTherm System (2024), 1 descendant of its own
- K234140: VIVA combo RF System (VIVA combo RF System) (2024), 1 descendant of its own
- K172012: star RF Electrode, VIVA RF Electrode (2018), 1 descendant of its own
- K252833: VIVA combo RF System (2026), 0 descendants of its own

## Indications for use
The VIVA combo RF Ablation System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

Source page: https://510kreport.com/device/K163450
Methodology: https://510kreport.com/methodology