PMU

Containment System, Laparoscopic Power Morcellation, With Instrument Port

产品代码

PMU

器械名称

Containment System, Laparoscopic Power Morcellation, With Instrument Port

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 884.4050

FDA 专业组

Obstetrics/Gynecology

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

1 件

其中 Summary 已存档

1 份，可直接下载

FDA 历史累计 510(k)

4 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

Use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The device is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

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)（1 件）

数据窗口为最近三年。最新一件：2025-04-15。

其中 1 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。