# K222001: Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Curaway Medical Technology Co., Ltd.
- Decided: Jun 8, 2023 after 336 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: 12 generations back to K942299 (1995). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183385: NanoKnife System, Angiodynamics (2019) Summary page 4.

## Indications for use
The Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissue. The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation Ablation Generator of CuraWay indicated for the surgical ablation of soft tissue.

Source page: https://510kreport.com/device/K222001
Methodology: https://510kreport.com/methodology