OCX
- 产品代码
- OCX
- 器械名称
- Endoscopic Irrigation/Suction System
- 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)
- 9 件
- 其中 Summary 已存档
- 7 份,可直接下载
- FDA 历史累计 510(k)
- 93 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
该代码近三年的 510(k)(9 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K251986 | 2025-09-26 | Olympus Medical Systems Corporation | AUXILIARY WATER TUBE MAJ-855 | |
| K251997 | 2025-09-25 | Olympus Medical Systems Corporation | Single-Use Biopsy Valve (MAJ-1555) | |
| K242586 | 2025-05-22 | Ovesco Endoscopy AG | ArgoCap (200.52) | — |
| K241704 | 2025-03-20 | Hangzhou AGS MedTech Co., Ltd. | Endoscopic Water Pump | |
| K242357 | 2024-10-07 | Olympus Medical Systems Corporation | Water Container (MAJ-901); Water Container (MAJ-902) | |
| K241874 | 2024-09-24 | Hobbs Medical, Inc. | Aspiration Catheter (2189) | |
| K242134 | 2024-08-20 | Finemedix Co., Ltd. | ClearCap Distal Attachment | |
| K233442 | 2024-05-21 | Biotex, Inc. | troCarWash System | FDA |
| K230773 | 2023-11-21 | Zhejiang Chuangxiang Medical Technolog | Endoscopy Irrigation Tubing |
FDA 官方分类页: OCX
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。