QNM

Mountable Electromechanical Surgical System For Transluminal Approaches

产品代码
QNM
器械名称
Mountable Electromechanical Surgical System For Transluminal Approaches
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 878.4961
FDA 专业组
General, Plastic Surgery
上市路径
需提交 510(k) 上市前通告
该代码近三年的 510(k)
7 件
其中 Summary 已存档
7 份,可直接下载
FDA 历史累计 510(k)
8 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.

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)(7 件)

数据窗口为最近三年。最新一件:2025-07-08。

510(k) 号批准日期申请人器械名称摘要
K2517612025-07-08Momentis Surgical , Ltd.Anovo Surgical System (Model 6Ne); Anovo Instrument …PDF
K2505912025-06-06Momentis Surgical , Ltd.Anovo Surgical System (6Ne)PDF
K2510562025-05-02Momentis Surgical , Ltd.Anovo Instrument ARM Curved Scissors ; Anovo Instrum…PDF
K2431822025-02-03Momentis Surgical , Ltd.Anovo Instrument ARM Curved Scissors; Anovo Instrume…PDF
K2421572024-10-21Momentis Surgical , Ltd.Anovo Surgical System (Model 6Ne)PDF
K2419072024-10-02Momentis Surgical , Ltd.Anovo Surgical System (model 6N)PDF
K2321462023-09-14Momentis Surgical , Ltd.Anovo PedestalPDF

其中 7 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: QNM
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。