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FED

Endoscopic Access Overtube, Gastroenterology-Urology

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)
21 件
其中 Summary 已存档
18 份,可直接下载
FDA 历史累计 510(k)
102 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(21 件)

数据窗口为最近三年。最新一件:2026-08-04。

510(k) 号批准日期申请人器械名称摘要
K2619152026-08-04Boston Scientific CorporationNavigator™ Flex Ureteral Access Sheath SetPDF
K2609652026-04-13Calyxo, Inc.CVAC Aspiration SystemPDF
K2605212026-04-06Zhuhai Pusen Medical Technology Co., L…ClearEVAC Ureteral Aspirating Access Sheath (PUS-100…PDF
K2525722025-10-07Prodeon Medical, Inc.Prodeon Urethral Sheath SystemPDF
K2501282025-09-19Anhui Happiness Workshop Medical Instr…Single Use Suction-Evacuation Ureteral Access SheathPDF
K2501322025-09-05Zhejiang YiGao Medical Technology Co.,…Ureteral Access SheathPDF
K2506952025-07-08Shenzhen HugeMed Medical Technical Dev…Single-use Ureteral Access SheathPDF
K2515992025-07-03Hunan Vathin Medical Instrument Co., L…Single-use Ureteral Access SheathPDF
K2505852025-06-27Cathegenix (Xiamen) Co., Ltd.LumenaTM Ureteral Access SheathFDA
K2504522025-06-02MacroLux Medical Technology Co., Ltd.CoralWell™ Single-use Ureteral Access Sheath (NS-083…—
K2437102025-04-11Shenzhen Trious Medical Technology Co.…Disposable ureteral access sheathPDF
K2505172025-03-21Boston Scientific CorporationNavigator™ HD Ureteral Access Sheath Set 11/13 F x 2…PDF
K2438202025-01-31Dornier Medtech AmericaHoover Negative Pressure Access Sheath (Hoover) (Hoo…PDF
K2430252025-01-30Seplou (Zhuhai) Co., Ltd.Ureteral Access SheathPDF
K2421732024-11-12Coloplast Corp.Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL…PDF
K2430912024-11-01Fujifilm CorporationOver-tube (TR-1108A)PDF
K2401672024-10-08Hunan Vathin Medical Instrument Co., L…Single-use Ureteral Access SheathPDF
K2411812024-08-02Dongguan Zsr Biomedical Technology Com…Disposable Ureteral Guide SheathFDA
K2408532024-06-27Neptune Medical, Inc.Pathfinder® CR SystemPDF
K2334722024-02-02Calyxo, Inc.CVAC Aspiration System + CVAC Image ProcessorPDF
K2307522023-09-15FUJIFILM Healthcare Americas Corporati…Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tub…PDF

其中 18 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。