HAW
- 产品代码
- HAW
- 器械名称
- Neurological Stereotaxic Instrument
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 882.4560
- 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)
- 424 件
该代码近三年的 510(k)（23 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261932 | 2026-08-05 | Elekta Solutions AB | Leksell® Vantage Stereotactic System | |
| K253663 | 2026-05-01 | Zeta Surgical, Inc. | Zeta Navigation System | |
| K253379 | 2026-03-26 | Medtronic Navigation, Inc. | Stealth AXiS Cranial clinical application | |
| K231897 | 2025-10-21 | Medivis, Inc. | NeuroAlign software | |
| K251317 | 2025-09-05 | Intravent Medical Partners | SOLOPASS 2.0 System | |
| K250893 | 2025-09-04 | Bayer Medical Care, Inc. | Ball Joint Guide Array (66295) | |
| K250505 | 2025-07-09 | Phasor Health, LLC | EZ-FIDUCIALS | |
| K242575 | 2025-05-23 | Brain Navi Biotechnology Co., Ltd. | Stereotaxic Guiding Surgical Devices, NaoTrac S | |
| K241327 | 2025-02-05 | Claronav | Navient Image Guide Navigation System (955-NC-NC), C | FDA |
| K243698 | 2025-01-28 | Brainlab AG | Alignment System Cranial, with Alignment Software Cr | |
| K243657 | 2025-01-24 | ClearPoint Neuro, Inc. | ClearPoint System (Software Version 3.0) | FDA |
| K241333 | 2025-01-17 | Koh Young Technology, Inc. | Geniant Cranial (Navigated Neurosurgical Positioning | |
| K242480 | 2024-12-27 | 7D Surgical ULC | FLASH EVD System (10-0002) | |
| K242351 | 2024-10-04 | Zeta Surgical, Inc. | Zeta Cranial Navigation System (ZNS131-US) | |
| K233703 | 2024-04-26 | ClearPoint Neuro, Inc. | Bone Anchor (NGS-BA-01) | |
| K233155 | 2024-01-12 | ClearPoint Neuro, Inc. | ClearPointer Optical Navigation Wand | |
| K233141 | 2024-01-12 | ClearPoint Neuro, Inc. | SmartFrame OR | |
| K233144 | 2024-01-12 | ClearPoint Neuro, Inc. | ClearPoint Bone Screw Fiducials | |
| K233903 | 2024-01-10 | Zeta Surgical, Inc. | Zeta Cranial Navigation System (ZNS131-US) | |
| K233243 | 2023-11-27 | ClearPoint Neuro, Inc. | ClearPoint System (Software Version 2.2) | |
| K231976 | 2023-10-19 | Medtronic Navigation, Inc. | StealthStation Cranial Software, v3.1.5 (9735585) | |
| K232102 | 2023-09-15 | ClearPoint Neuro, Inc. | ClearPoint Array System (Version 1.2) | |
| K223864 | 2023-09-09 | Brainlab AG | Alignment System Cranial, Alignment Software Cranial |
FDA 官方分类页： HAW
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。