HAW — Neurological Stereotaxic Instrument Class II
FDA product code HAW covers "Neurological Stereotaxic Instrument", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HAW
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253663 | zeta surgical | Zeta Navigation System | May 1, 2026 |
| K253379 | medtronic navigation | Stealth AXiS Cranial clinical application | March 26, 2026 |
| K231897 | medivis | NeuroAlign software | October 21, 2025 |
| K251317 | intravent medical partners | SOLOPASS 2.0 System | September 5, 2025 |
| K250893 | bayer medical care | Ball Joint Guide Array (66295) | September 4, 2025 |
| K250505 | phasor health | EZ-FIDUCIALS | July 9, 2025 |
| K242575 | brain navi biotechnology co | Stereotaxic Guiding Surgical Devices, NaoTrac S | May 23, 2025 |
| K241327 | claronav | Navient Image Guide Navigation System (955-NC-NC), Cranial | February 5, 2025 |
| K243698 | brainlab | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignm | January 28, 2025 |
| K243657 | clearpoint neuro | ClearPoint System (Software Version 3.0) | January 24, 2025 |
| K241333 | koh young technology | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | January 17, 2025 |
| K242480 | 7d surgical ulc | FLASH EVD System (10-0002) | December 27, 2024 |
| K242351 | zeta surgical | Zeta Cranial Navigation System (ZNS131-US) | October 4, 2024 |
| K233703 | clearpoint neuro | Bone Anchor (NGS-BA-01) | April 26, 2024 |
| K233144 | clearpoint neuro | ClearPoint Bone Screw Fiducials | January 12, 2024 |
| K233155 | clearpoint neuro | ClearPointer Optical Navigation Wand | January 12, 2024 |
| K233141 | clearpoint neuro | SmartFrame OR | January 12, 2024 |
| K233903 | zeta surgical | Zeta Cranial Navigation System (ZNS131-US) | January 10, 2024 |
| K233243 | clearpoint neuro | ClearPoint System (Software Version 2.2) | November 27, 2023 |
| K231976 | medtronic navigation | StealthStation Cranial Software, v3.1.5 (9735585) | October 19, 2023 |