FDF
- 产品代码
- FDF
- 器械名称
- Colonoscope 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)
- 114 件
FDA 分类定义
To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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)（13 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261015 | 2026-08-21 | Gi View, Ltd. | Solo Scope Colonoscope System 摘要 |
| K261587 | 2026-07-02 | BPEndo, LLC | Insufflation Retention Device (IRD) (11173-325-101) 摘要 |
| K260423 | 2026-05-28 | Yangzhou Fartley Medical Instrument Te | Disposable Endoscopic Distal Attachments 摘要 |
| K252457 | 2026-01-30 | Shanghai SeeGen Photoelectric Technolo | Disposable Distal End Tape Hood 摘要 |
| K244029 | 2025-09-24 | Endorobotics Co., Ltd. | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) 摘要 |
| K243261 | 2025-05-23 | Fujifilm Corporation | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endosco 摘要 |
| K250432 | 2025-05-15 | Olympus Medical Systems Corporation | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF 摘要 |
| K242110 | 2025-01-03 | Pentax of America, Inc. | PENTAX Medical Video Colonoscope (EC38-i20cWL) 摘要 |
| K242325 | 2024-10-04 | Actuated Medical, Inc. | GripTract-GI Endoscopic Tissue Manipulator Lower GI 摘要 |
| K232043 | 2024-02-16 | Guangzhou Red Pine Medical Instrument | Endoscopic Video Image Processor (RP-IPD-V2000A, RP 摘要 |
| K231254 | 2023-11-03 | Actuated Medical, Inc. | GripTract-GI Endoscopic Tissue Manipulator 摘要 |
| K232922 | 2023-10-20 | Motus GI Medical Technologies , Ltd. | Pure-Vu EVS System 摘要 |
| K230332 | 2023-09-15 | Ambu A/S | Ambu® aScope Colon; Ambu® aBox 2 摘要 |
FDA 官方分类页： FDF
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。