NKN

Syringe, Piston, Reprocessed

产品代码

NKN

器械名称

Syringe, Piston, Reprocessed

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 880.5860

FDA 专业组

General Hospital

上市路径

需提交 510(k) 上市前通告

FDA 分类定义

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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）。