NLV

Electrode, Flexible Suction Coagulator, Reprocessed

产品代码: NLV
器械名称: Electrode, Flexible Suction Coagulator, Reprocessed
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 876.4300
FDA 专业组: Gastroenterology, Urology
上市路径: 需提交 510(k) 上市前通告

FDA 分类定义

The "electorde, flexible suction coagulator, reprocessed" is intended to be used endoscopically to provide simultaneous suction of fluids and coagulation of tissue. 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）。

FDA 官方分类页： NLV

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。