NEY
- 产品代码
- NEY
- 器械名称
- System, Ablation, Microwave And Accessories
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.4400
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 13 件
- 其中 Summary 已存档
- 12 份，可直接下载
- FDA 历史累计 510(k)
- 68 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（13 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252632 | 2026-03-02 | Nanjing Dewen Medical Technology Co., | Microwave Ablation Device | |
| K253771 | 2026-03-02 | Nanjing Devin Medical Technology Co., | Disposable Microwave Ablation Antenna (DW-XR-II1, DW | |
| K250718 | 2025-08-08 | Emblation Limited | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | |
| K241827 | 2024-09-26 | Canyon Medical, Inc. | Microwave Ablation Generator (KY-2000A, KY-2100A) | |
| K241825 | 2024-09-20 | Canyon Medical, Inc. | Microwave Ablation Antennas | |
| K240480 | 2024-07-19 | Varian Medical Systems, Inc. | IntelliBlate Microwave Ablation System Console (IB-C | |
| K240784 | 2024-05-29 | Varian Medical Systems, Inc. | Temperature Sensor Probe (ABL-18TP20) | |
| K240518 | 2024-04-23 | Emblation Limited | swiftPro System | |
| K233838 | 2024-03-28 | Medtronic, Inc. | Emprint Ablation System with Thermosphere Technology | FDA |
| K233140 | 2024-01-31 | Hygea Medical Technology Co., Ltd. | Microwave Ablation Device (Exceed S10U); Sterile Mic | |
| K231738 | 2023-11-16 | Neuwave Medical, Inc. | NEUWAVE Microwave Ablation System and Accessories | |
| K232240 | 2023-11-13 | Betters(Suzhou) Medical Co., Ltd. | Microwave Ablation System (BD-GT) | |
| K232241 | 2023-11-13 | Betters(Suzhou) Medical Co., Ltd. | Disposable Microwave Ablation Needle (T-1408, T-1410 |
FDA 官方分类页： NEY
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。