# K190052: Radio Frequency Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Decided: Jun 25, 2019 after 165 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: 6 generations back to K870028 (1987). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 4.

## Most influential descendants
- K233705: CellFX Percutaneous Electrode System (SYS3000) (2024), 1 descendant of its own
- K240782: CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) (2024), 0 descendants of its own

## Indications for use
The Radio Frequency Ablation System is intended for coagulation and ablation of soft tissue. It is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K190052
Methodology: https://510kreport.com/methodology