GWG
- 产品代码
- GWG
- 器械名称
- Endoscope, Neurological
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 882.1480
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 93 件
FDA 分类定义
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
该代码近三年的 510(k)(9 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253602 | 2026-06-04 | Stryker Endoscopy | Precision S 4K Sinuscope | |
| K253679 | 2026-05-08 | Stryker Instruments | Hydro Irrigation System | |
| K243429 | 2025-05-21 | Hjy Smart Medical Device Co., Ltd. | HJY VisualNext 3D Endoscopic Vision System | |
| K250752 | 2025-04-09 | Integra LifeSciences Corporation | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgi | |
| K233391 | 2024-08-21 | VPIX Medical, Inc. | cCeLL - In vivo | |
| K223615 | 2023-11-21 | Clarus Medical, LLC | Digital ClarusScope System, Digital NeuroPEN System | |
| K232618 | 2023-10-27 | Rebound Therapeutics Corporation | Aurora Surgiscope System | |
| K230125 | 2023-10-13 | Clearmind Biomedical | Neuroblade System | |
| K232159 | 2023-09-21 | Carl Zeiss Meditec, AG | QEVO System |
FDA 官方分类页: GWG
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。