K242687

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) 号
K242687
器械名称
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)
申请人
AngioDynamics, Inc. MA · US
产品代码
OAB — Low Energy Direct Current Thermal Ablation System
批准日期
2024-12-06
受理日期
2024-09-06
决定
Substantially Equivalent
审查途径
Traditional
咨询委员会
General, Plastic Surgery
PDF下载 510(k) Summary本站存档 · 1.0 MB · FDA 公有领域文件

也可从 FDA 官方下载: K242687.pdf

FDA 官方记录: K242687
数据来自 openFDA 510(k) 数据集(CC0 公有领域),以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。