Electroporation System (N3000)— 510(k) K240376

Substantially Equivalent

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

FDA 510(k) clearance K240376 for Electroporation System (N3000), Substantially Equivalent on 2024-10-04. Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd..

Clearance details

Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Product code: Code OAB
Advisory panel: General, Plastic Surgery
Date received: 2024-02-07
Decision date: 2024-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cixi, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code OAB

product code OAB

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.