# K233705: CellFX Percutaneous Electrode System (SYS3000)

- Pathway: 510(k) (Traditional)
- Applicant: Pulse Biosciences, Inc.
- Decided: Mar 8, 2024 after 109 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: 7 generations back to K870028 (1987). 18 ancestors in all.
1 later device descends 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)
- K190052: Radio Frequency Ablation System, Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- 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 CellFX Percutaneous Electrode System is intended for ablation of soft tissue in percutaneous and intraoperative surgical procedures. The CellFX Percutaneous Electrode System (Percutaneous Electrode) is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K233705
Methodology: https://510kreport.com/methodology