Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) → HAW — Neurological Stereotaxic Instrument # HAW · Neurological Stereotaxic Instrument _Neurology · 21 CFR 882.4560 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW ## Overview - **Product Code:** HAW - **Device Name:** Neurological Stereotaxic Instrument - **Regulation:** [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## 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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K253379.md) | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | Mar 26, 2026 | SESE | | [K231897](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K231897.md) | NeuroAlign software | Medivis, Inc. | Oct 21, 2025 | SESE | | [K251317](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K251317.md) | SOLOPASS 2.0 System | Intravent Medical Partners | Sep 5, 2025 | SESE | | [K250893](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K250893.md) | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | Sep 4, 2025 | SESE | | [K250505](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K250505.md) | EZ-FIDUCIALS | Phasor Health, LLC | Jul 9, 2025 | SESE | | [K242575](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K242575.md) | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | May 23, 2025 | SESE | | [K241327](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K241327.md) | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | Feb 5, 2025 | SESE | | [K243698](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K243698.md) | 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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K243657.md) | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | Jan 24, 2025 | SESE | | [K241333](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K241333.md) | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | Jan 17, 2025 | SESE | | [K242480](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K242480.md) | FLASH EVD System (10-0002) | 7D Surgical ULC | Dec 27, 2024 | SESE | | [K242351](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K242351.md) | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | Oct 4, 2024 | SESE | | [K233703](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K233703.md) | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | Apr 26, 2024 | SESE | | [K233155](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K233155.md) | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | Jan 12, 2024 | SESE | | [K233144](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K233144.md) | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | Jan 12, 2024 | SESE | | [K233141](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K233141.md) | SmartFrame OR | ClearPoint Neuro, Inc. | Jan 12, 2024 | SESE | | [K233903](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K233903.md) | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | Jan 10, 2024 | SESE | | [K233243](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K233243.md) | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | Nov 27, 2023 | SESE | | [K231976](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K231976.md) | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | Oct 19, 2023 | SESE | | [K232102](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K232102.md) | 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 - Image-Guided Neurologics, Inc. — 15 clearances - Surgical Navigation Technologies, Inc. — 15 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com