FDT
- 产品代码
- FDT
- 器械名称
- Duodenoscope And Accessories, Flexible/Rigid
- 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)
- 35 件
FDA 分类定义
To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
该代码近三年的 510(k)（6 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K251861 | 2026-03-09 | Fujifilm Corporation | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endosco 摘要 |
| K253646 | 2026-02-22 | Olympus Medical Systems Corp. | Single Use Distal Cover MAJ-2315 (MAJ-2315) 摘要 |
| K251867 | 2025-09-19 | Olympus Medical Systems Corp. | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V ( 摘要 |
| K250701 | 2025-06-05 | Olympus Medical Systems Corp. | Evis Exera III Duodenovideoscope Olympus TJF-Q190V ( 摘要 |
| K233942 | 2024-08-01 | Pentax of America, Inc. | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PEN 摘要 |
| K233886 | 2024-04-16 | Ambu A/S | Ambu® aScope Duodeno 2, Ambu® aBox 2 摘要 |
FDA 官方分类页： FDT
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。