NLW

Electrode, Electrosurgical, Active, Urological, Reprocessed

产品代码

NLW

器械名称

Electrode, Electrosurgical, Active, Urological, 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 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 "electrode, electrosurgical, active, urological, reprocessed" is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current. 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) 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）。