NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)— 510(k) K242687

Substantially Equivalent

AngioDynamics, Inc.

FDA 510(k) clearance K242687 for NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010), Substantially Equivalent on 2024-12-06. Applicant: AngioDynamics, Inc..

Clearance details

Applicant: AngioDynamics, Inc.
Product code: Code OAB
Advisory panel: General, Plastic Surgery
Date received: 2024-09-06
Decision date: 2024-12-06
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.