K250898

Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)

510(k) 号
K250898
器械名称
Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)
申请人
Stryker Sustainability Solutions AZ · US
产品代码
NLQ — Single-Use Reprocessed Ultrasonic Surgical Instrumen
批准日期
2025-08-14
受理日期
2025-03-25
决定
Substantially Equivalent
审查途径
Traditional
咨询委员会
Unknown
PDF下载 510(k) Summary本站存档 · 0.9 MB · FDA 公有领域文件

也可从 FDA 官方下载: K250898.pdf

FDA 官方记录: K250898
数据来自 openFDA 510(k) 数据集(CC0 公有领域),以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。