HAW — Neurological Stereotaxic Instrument Class II
FDA Device Classification
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 |
|---|
| 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 |
| K233155 | clearpoint neuro | ClearPointer Optical Navigation Wand | January 12, 2024 |
| K233141 | clearpoint neuro | SmartFrame OR | January 12, 2024 |
| K233144 | clearpoint neuro | ClearPoint Bone Screw Fiducials | 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 |
| K232102 | clearpoint neuro | ClearPoint Array System (Version 1.2) | September 15, 2023 |
| K223864 | brainlab | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cr | September 9, 2023 |