NanoKnife Generator (H78720300351US0)— 510(k) K253198

Substantially Equivalent

Angiodynamics

FDA 510(k) clearance K253198 for NanoKnife Generator (H78720300351US0), Substantially Equivalent on 2026-03-24. Applicant: Angiodynamics.

Clearance details

Applicant: Angiodynamics
Product code: Code OAB
Advisory panel: General, Plastic Surgery
Date received: 2025-09-26
Decision date: 2026-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

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.