K240376
- 510(k) number
- K240376
- Device name
- Electroporation System (N3000)
- Applicant
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. CN
- Product code
- OAB — Low Energy Direct Current Thermal Ablation System
- Decision date
- 2024-10-04
- Date received
- 2024-02-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240376.pdf
Official FDA record: K240376
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.