NRN

Leeches, Medicinal

产品代码

NRN

器械名称

Leeches, Medicinal

管理类别

第 U 类（Unclassified）

FDA 专业组

Unknown

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

3 件

FDA 分类定义

The device is a medicinal leech (hirudo medicinalis) belonging to the annelida worm classification. The animal is a bloodsucking aquatic animal living in fresh water. The device should be indicated as: "an adjunct to the graft tissue healing when problems of venous congestion may delay healing, or to overcome the problem of venous congestion by creating prolonged localized bleeding." See Federal Register Notice at 89 FR 106521 “Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches” (FRN) (FDA-2024-N-5702)

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）。