SHU
- 产品代码
- SHU
- 器械名称
- Appendiceal Scope And Accessories, Flexible
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 876.1500
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 1 件
- 其中 Summary 已存档
- 0 份,可直接下载
- FDA 历史累计 510(k)
- 1 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
Inserted into the lower gastrointestinal lumen via the anus to provide visualization and therapeutic access to the appendix. Navigation to the appendix may be accomplished by inserting the flexible appendiceal scope into the working channel of a colonoscope. Does not include laparoscopes, telescopes, or other rigid scopes that are surgically inserted into the body through the abdominal wall.
该代码近三年的 510(k)(1 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252492 | 2026-04-24 | Micro-Tech (Nanjing) Co., Ltd. | Visualized Access and Delivery Catheter; PB Digital | FDA |
FDA 官方分类页: SHU
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。