NLQ
- 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).
该代码近三年的 510(k)(3 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K250898 | 2025-08-14 | Stryker Sustainability Solutions | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed | |
| K241606 | 2024-07-03 | Stryker Sustainability Solutions | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm | |
| K233471 | 2024-02-20 | Stryker Sustainability Solutions | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm |
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。