K222001 is an FDA 510(k) clearance for the Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe. This device is classified as a Low Energy Direct Current Thermal Ablation System (Class II - Special Controls, product code OAB).
Submitted by Zhejiang Curaway Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 8, 2023, 336 days after receiving the submission on July 7, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Ablation Of Soft Tissue.
| 510(k) Number | K222001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2022 |
| Decision Date | June 08, 2023 |
| Days to Decision | 336 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OAB - Low Energy Direct Current Thermal Ablation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Ablation Of Soft Tissue |