# K240376: Electroporation System (N3000)

- Pathway: 510(k) (Traditional)
- Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Decided: Oct 4, 2024 after 240 days
- Product code: OAB (Low Energy Direct Current Thermal Ablation System)
- 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: 10 generations back to K942299 (1995). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102329: Nanoknife System, AngioDynamics, Inc. (2011) Summary page 5.

## Indications for use
The Dophi Electroporation System is intended for surgical ablation of soft tissue by irreversible electroporation.

Source page: https://510kreport.com/device/K240376
Methodology: https://510kreport.com/methodology