NMJ

Clip, Implantable, Reprocessed

产品代码

NMJ

器械名称

Clip, Implantable, Reprocessed

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 878.4300

FDA 专业组

General, Plastic Surgery

上市路径

需提交 510(k) 上市前通告

标记

属植入器械

FDA 历史累计 510(k)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing. It is not absorbable. This device is indicated for reuse/reprocessing. 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）。