K240376 is an FDA 510(k) clearance for the Electroporation System (N3000). This device is classified as a Low Energy Direct Current Thermal Ablation System (Class II - Special Controls, product code OAB).
Submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on October 4, 2024, 240 days after receiving the submission on February 7, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Ablation Of Soft Tissue.
| 510(k) Number | K240376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2024 |
| Decision Date | October 04, 2024 |
| Days to Decision | 240 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 |