ODC
- 产品代码
- ODC
- 器械名称
- Endoscope Channel Accessory
- 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)
- 21 件
- 其中 Summary 已存档
- 18 份，可直接下载
- FDA 历史累计 510(k)
- 72 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
To give the endoscope channel additional or improved functionality.
该代码近三年的 510(k)（21 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252933 | 2026-06-12 | Dyne Medical Group, Inc. | DYNE PORT | |
| K250145 | 2025-10-17 | Endosound, Inc. | Biopsy Port Adapter | |
| K252910 | 2025-10-09 | Boston Scientific | Orca Air/Water and Suction Valves | |
| K250949 | 2025-07-16 | Olympus Medical Systems Corporation | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | |
| K250732 | 2025-06-20 | Yangzhou Fartley Medical Instrument Te | Disposable Endoscopy Valve Set | |
| K241842 | 2025-03-19 | Olympus Medical Systems Corporation | Luer-Split MAJ-2092 | |
| K250140 | 2025-02-20 | Steris Corparation | Defendo Fujifilm 700 Single Use Cleaning Adapter | |
| K243075 | 2024-11-08 | STERIS Corporation | Defendo Single Use Cleaning Adapter for Olympus Endo | FDA |
| K242742 | 2024-10-11 | STERIS Corporation | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for O | |
| K241285 | 2024-10-01 | Alton (Shanghai) Medical Instruments C | Disposable Endoscope Valves Set (AF series) | |
| K232067 | 2024-03-22 | Medivators (A Subsidiary of Steris Cor | Defendo Fujifilm 500/600 Single Use Air/Water Valve, | |
| K232327 | 2024-03-15 | Endostart S.R.L. | Endorail | |
| K240352 | 2024-03-06 | STERIS Corporation | Defendo Single Use Cleaning Adapter for Olympus Endo | |
| K232004 | 2024-03-06 | Medivators (A Subsidiary of Steris Cor | Defendo Pentax Single Use Biopsy Valve, Defendo Pent | FDA |
| K240098 | 2024-02-09 | STERIS Corporation | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for O | |
| K232329 | 2023-12-21 | Medivators (A Subsidiary of Steris Cor | Defendo Fujifilm 700 Single Use Biopsy Valve; Defend | |
| K232249 | 2023-12-01 | Pentax of America, Inc. | PENTAX Medical Gas/Water Feeding Valve OE-B14 | |
| K232244 | 2023-11-29 | Changzhou Endoclean Medical Device Co. | Disposable Endoscope Valves System | |
| K222499 | 2023-11-22 | Shanghai SeeGen Photoelectric Technolo | Disposable Endoscope Valves Kit | |
| K232951 | 2023-10-20 | Steris | BioShield Biopsy Valve (00711124); BioShield Biopsy | |
| K232118 | 2023-10-16 | Ga Health Company Limited | ANDORATE® Valve Kit | FDA |
FDA 官方分类页： ODC
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。