FBN
- 产品代码
- FBN
- 器械名称
- Choledochoscope 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)
- 43 件
FDA 分类定义
to examine and perform procedures within the bile ducts. 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)（9 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K254153 | 2026-04-03 | Mirco-Tech (Nanjing) Co., Ltd. | Single-use Video Scope; PB Digital Controller 摘要 |
| K253139 | 2026-03-19 | Mirco-Tech (Nanjing) Co., Ltd. | Disposable Distal Cap 摘要 |
| K251338 | 2026-01-20 | Scivita Medical Technology Co., Ltd. | Cholangioscope Visualization System (Single-use Vide 摘要 |
| K251170 | 2025-09-12 | Tangent Endoscopy, LLC | Tangent Single-Use Digital System: Tangent Single-Us 摘要 |
| K243535 | 2025-03-07 | Shanghai SeeGen Photoelectric Technolo | Flexible Video-Choledochoscope (CHV-110J-U); Flexibl 摘要 |
| K241444 | 2025-01-21 | Shenzhen HugeMed Medical Technical Dev | Biliary Pancreaticobiliary Scope System 摘要 |
| K233752 | 2024-05-02 | CenterPoint Systems, LLC | Dragonfly Pancreaticobiliary Scope; Dragonfly Digi 摘要 |
| K231497 | 2024-03-06 | Shenzhen HugeMed Medical Technical Dev | Choledochoscope System 摘要 |
| K231105 | 2023-10-17 | Shanghai AnQing Medical Instrument Co. | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-2 摘要 |
FDA 官方分类页： FBN
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。