K240572
- 510(k) 号
- K240572
- 器械名称
- Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6)
- 申请人
- Covidien, LLC CO · US
- 产品代码
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- 批准日期
- 2024-07-01
- 受理日期
- 2024-02-29
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- General, Plastic Surgery
FDA 官方记录: K240572
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。