HAW · Neurological Stereotaxic Instrument
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | HAW |
|---|---|
| Device Name | Neurological Stereotaxic Instrument |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 422)
Showing 20 most recent of 422 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | Mar 26, 2026 | SESE |
| K231897 | NeuroAlign software | Medivis, Inc. | Oct 21, 2025 | SESE |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | Sep 5, 2025 | SESE |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | Sep 4, 2025 | SESE |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | Jul 9, 2025 | SESE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | May 23, 2025 | SESE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | Feb 5, 2025 | SESE |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab AG | Jan 28, 2025 | SESE |
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | Jan 24, 2025 | SESE |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | Jan 17, 2025 | SESE |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | Dec 27, 2024 | SESE |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | Oct 4, 2024 | SESE |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | Apr 26, 2024 | SESE |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | Jan 12, 2024 | SESE |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | Jan 12, 2024 | SESE |
| K233141 | SmartFrame OR | ClearPoint Neuro, Inc. | Jan 12, 2024 | SESE |
| K233903 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | Jan 10, 2024 | SESE |
| K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | Nov 27, 2023 | SESE |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | Oct 19, 2023 | SESE |
| K232102 | ClearPoint Array System (Version 1.2) | ClearPoint Neuro, Inc. | Sep 15, 2023 | SESE |
Top Applicants
- Brainlab AG — 57 clearances
- Medtronic Navigation, Inc. — 18 clearances
- Elekta Instrument AB — 16 clearances
- Surgical Navigation Technologies, Inc. — 15 clearances
- Image-Guided Neurologics, Inc. — 15 clearances
