HAW
- Product code
- HAW
- Device name
- Neurological Stereotaxic Instrument
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4560
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 23
- Summaries archived here
- 21 (direct download)
- 510(k) clearances (all years, FDA)
- 424 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (23)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| 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… |
Official FDA classification page: HAW
Classification and pathway per current FDA publications. Data from openFDA (CC0).