NLQ

Single-Use Reprocessed Ultrasonic Surgical Instruments

产品代码
NLQ
器械名称
Single-Use Reprocessed Ultrasonic Surgical Instruments
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)
27 件

FDA 分类定义

Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). 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)。

该代码近三年的 510(k)(3 件)

数据窗口为最近三年。最新一件:2025-08-14。

510(k) 号批准日期申请人器械名称摘要
K2508982025-08-14Stryker Sustainability SolutionsReprocessed HARMONIC 700 Shears (HAR723/Reprocessed PDF
K2416062024-07-03Stryker Sustainability SolutionsReprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cmPDF
K2334712024-02-20Stryker Sustainability SolutionsReprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cmPDF

其中 3 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: NLQ
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。