FED
- 产品代码
- FED
- 器械名称
- Endoscopic Access Overtube, Gastroenterology-Urology
- 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)
- 102 件
FDA 分类定义
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
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 |
|---|---|---|---|
| K261915 | 2026-08-04 | Boston Scientific Corporation | Navigator Flex Ureteral Access Sheath Set 摘要 |
| K260965 | 2026-04-13 | Calyxo, Inc. | CVAC Aspiration System 摘要 |
| K260521 | 2026-04-06 | Zhuhai Pusen Medical Technology Co., L | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100 摘要 |
| K252572 | 2025-10-07 | Prodeon Medical, Inc. | Prodeon Urethral Sheath System 摘要 |
| K250128 | 2025-09-19 | Anhui Happiness Workshop Medical Instr | Single Use Suction-Evacuation Ureteral Access Sheath 摘要 |
| K250132 | 2025-09-05 | Zhejiang YiGao Medical Technology Co., | Ureteral Access Sheath 摘要 |
| K250695 | 2025-07-08 | Shenzhen HugeMed Medical Technical Dev | Single-use Ureteral Access Sheath 摘要 |
| K251599 | 2025-07-03 | Hunan Vathin Medical Instrument Co., L | Single-use Ureteral Access Sheath 摘要 |
| K250585 | 2025-06-27 | Cathegenix (Xiamen) Co., Ltd. | LumenaTM Ureteral Access Sheath 摘要 |
| K250452 | 2025-06-02 | MacroLux Medical Technology Co., Ltd. | CoralWell Single-use Ureteral Access Sheath (NS-083 |
| K243710 | 2025-04-11 | Shenzhen Trious Medical Technology Co. | Disposable ureteral access sheath 摘要 |
| K250517 | 2025-03-21 | Boston Scientific Corporation | Navigator HD Ureteral Access Sheath Set 11/13 F x 2 摘要 |
| K243820 | 2025-01-31 | Dornier Medtech America | Hoover Negative Pressure Access Sheath (Hoover) (Hoo 摘要 |
| K243025 | 2025-01-30 | Seplou (Zhuhai) Co., Ltd. | Ureteral Access Sheath 摘要 |
| K242173 | 2024-11-12 | Coloplast Corp. | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL 摘要 |
| K243091 | 2024-11-01 | Fujifilm Corporation | Over-tube (TR-1108A) 摘要 |
| K240167 | 2024-10-08 | Hunan Vathin Medical Instrument Co., L | Single-use Ureteral Access Sheath 摘要 |
| K241181 | 2024-08-02 | Dongguan Zsr Biomedical Technology Com | Disposable Ureteral Guide Sheath 摘要 |
| K240853 | 2024-06-27 | Neptune Medical, Inc. | Pathfinder® CR System 摘要 |
| K233472 | 2024-02-02 | Calyxo, Inc. | CVAC Aspiration System + CVAC Image Processor 摘要 |
| K230752 | 2023-09-15 | FUJIFILM Healthcare Americas Corporati | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tub 摘要 |
FDA 官方分类页： FED
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。