Product code HAW
- Device name
- Neurological Stereotaxic Instrument
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4560
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2026-09-10 |
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | 2026-08-05 |
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026-05-01 |
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | 2026-03-26 |
| K231897 | NeuroAlign software | Medivis, Inc. | 2025-10-21 |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | 2025-09-05 |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025-09-04 |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | 2025-07-09 |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | 2025-02-05 |
| 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 | 2025-01-28 |
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025-01-24 |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2025-01-17 |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | 2024-12-27 |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-10-04 |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024-04-26 |
| K233141 | SmartFrame OR | ClearPoint Neuro, Inc. | 2024-01-12 |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | 2024-01-12 |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | 2024-01-12 |
| K233903 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-01-10 |
| K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | 2023-11-27 |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | 2023-10-19 |
| K232102 | ClearPoint Array System (Version 1.2) | ClearPoint Neuro, Inc. | 2023-09-15 |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Brainlab AG | 2023-09-09 |
| K230661 | Zeta Cranial Navigation System | Zeta Surgical | 2023-09-08 |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab AG | 2023-07-21 |
| K231103 | ROSA ONE Brain Application | Medtech S.A.S | 2023-07-20 |
| K231392 | NaviNetics Reusable Stereotactic System (NN1000) | Navinetics, Inc. | 2023-07-14 |
| K220072 | Sinobot X1 | Sinovation (Beijing) Medical Technology Co., Ltd. | 2023-06-18 |
| K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Brainlab AG | 2023-04-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04056481146702 | Curve Navigation | Brainlab SE | 2025-10-13 |
| 04056481144500 | Curve Navigation 17700 | Brainlab SE | 2023-05-22 |
| 04056481143503 | Kick 2 Navigation Station | Brainlab SE | 2021-05-31 |
| 04056481142520 | Curve Navigation 17700 | Brainlab SE | 2020-05-25 |
| 04056481140847 | Buzz Navigation (Ceiling Mounted) | Brainlab SE | 2018-10-31 |
| 04056481138011 | Curve 1.2 Dual Navigation Station | Brainlab SE | 2018-01-04 |
| 07613327004250 | ORTHOMAP | Stryker Leibinger GmbH & Co. KG | 2017-12-12 |
| 07613252450115 | ORTHOMAP | Stryker Leibinger GmbH & Co. KG | 2017-12-12 |
| 07613252450108 | ORTHOMAP | Stryker Leibinger GmbH & Co. KG | 2017-12-12 |
| 07613252449850 | ORTHOMAP | Stryker Leibinger GmbH & Co. KG | 2017-12-12 |
| 04056481006655 | Kick 2 Navigation Station | Brainlab SE | 2016-11-25 |
| 04056481005658 | Dispos. Clip-On Remote Control | Brainlab SE | 2016-09-15 |
| 04056481002503 | Patient Reference Attachment Arm for Skull Clamp | Brainlab SE | 2016-09-15 |
| 04056481002152 | Bl Pointer Straight-Extended | Brainlab SE | 2016-09-15 |
| 04056481006303 | Patient Reference Array for Skull Clamp | Brainlab SE | 2016-09-15 |
| 04056481006297 | Patient Reference Attachment for Skull Clamp | Brainlab SE | 2016-09-15 |
| 04056481006051 | Patient Reference T-Adapter for Skull Clamp | Brainlab SE | 2016-09-15 |
| 04056481004637 | Drapelink Interface Ict Calib Phantom | Brainlab SE | 2016-09-15 |
| 04056481004569 | Calibration Phantom Ict | Brainlab SE | 2016-09-15 |
| 04056481004552 | Interconnector Drapelink | Brainlab SE | 2016-09-15 |
| 04056481004545 | Cranial Reference Array Drapelink | Brainlab SE | 2016-09-15 |
| 04056481004538 | Adapter For Mayfield Skull Clamp | Brainlab SE | 2016-09-15 |
| 04056481004521 | Adapter For Doro Skull Clamp | Brainlab SE | 2016-09-15 |
| 04056481004514 | Base Long For Drapelink | Brainlab SE | 2016-09-15 |
| 04056481004507 | Base Short For Drapelink | Brainlab SE | 2016-09-15 |
| 04546540245038 | NA | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |
| 04546540651563 | NGENIUS | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |
| 07613252510932 | CRANIALMAP | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |
| 07613252510949 | CRANIALMAP | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |
| 07613327115048 | NA | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |