K232042
- 510(k) 号
- K232042
- 器械名称
- NexPort Trocar System (TS211001); NexPort Trocar System (TS211002); NexPort Trocar System (TS211003); NexPort Trocar System (TS211010); NexPort Trocar System (TS211011); NexPort Trocar System (TS211012); NexPort Trocar System (TS221001); NexPort Trocar System (TS221002); NexPort Trocar System (TS221003); NexPort Trocar System (TS221010); NexPort Trocar System (TS221011); NexPort Trocar System (TS221012); NexPort Trocar System (TS221020); NexPort Trocar System (TS221021);
- 申请人
- Mediconcepts Technology (Shenzhen) Company Limited CN
- 产品代码
- GCJ — Laparoscope, General & Plastic Surgery
- 批准日期
- 2023-10-20
- 受理日期
- 2023-07-10
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- Gastroenterology, Urology
FDA 官方记录: K232042
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。