K250898
- 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
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。