FDA Product Code
FDA Product Code HAW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 425 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2026-09-10 | Traditional | PDF ↗ |
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | 2026-08-05 | Traditional | PDF ↗ |
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026-05-01 | Traditional | PDF ↗ |
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | 2026-03-26 | Traditional | PDF ↗ |
| K231897 | NeuroAlign software | Medivis, Inc. | 2025-10-21 | Traditional | PDF ↗ |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | 2025-09-05 | Traditional | PDF ↗ |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025-09-04 | Traditional | PDF ↗ |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | 2025-07-09 | Traditional | PDF ↗ |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 | Traditional | PDF ↗ |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | 2025-02-05 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025-01-24 | Traditional | PDF ↗ |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2025-01-17 | Traditional | PDF ↗ |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | 2024-12-27 | Traditional | PDF ↗ |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-10-04 | Special | PDF ↗ |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024-04-26 | Traditional | PDF ↗ |
| K233141 | SmartFrame OR | ClearPoint Neuro, Inc. | 2024-01-12 | Traditional | PDF ↗ |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | 2024-01-12 | Traditional | PDF ↗ |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | 2024-01-12 | Traditional | PDF ↗ |
| K233903 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-01-10 | Special | PDF ↗ |
| K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | 2023-11-27 | Traditional | PDF ↗ |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | 2023-10-19 | Traditional | PDF ↗ |
| K232102 | ClearPoint Array System (Version 1.2) | ClearPoint Neuro, Inc. | 2023-09-15 | Special | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K230661 | Zeta Cranial Navigation System | Zeta Surgical | 2023-09-08 | Traditional | PDF ↗ |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab AG | 2023-07-21 | Traditional | PDF ↗ |
| K231103 | ROSA ONE Brain Application | Medtech S.A.S | 2023-07-20 | Traditional | PDF ↗ |
| K231392 | NaviNetics Reusable Stereotactic System (NN1000) | Navinetics, Inc. | 2023-07-14 | Traditional | PDF ↗ |
| K220072 | Sinobot X1 | Sinovation (Beijing) Medical Technology Co., Ltd. | 2023-06-18 | Traditional | PDF ↗ |
| K223552 | Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Brainlab AG | 2023-04-19 | Traditional | PDF ↗ |
| K223577 | Localite TMS Navigator TS | Localite GmbH | 2023-04-17 | Traditional | PDF ↗ |
| K221544 | MagVenture TMS Atlas Neuro Navigation System | Tonica Elektronik A/S | 2023-03-17 | Traditional | PDF ↗ |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2023-02-22 | Special | PDF ↗ |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System | Stryker Corporation | 2023-02-16 | Traditional | PDF ↗ |
| K222519 | ClearPoint System | ClearPoint Neuro, Inc. | 2022-09-16 | Special | PDF ↗ |
| K213989 | Cranial EM System | Brainlab AG | 2022-09-08 | Traditional | PDF ↗ |
| K220897 | Disposable Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2022-08-17 | Traditional | PDF ↗ |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | Medtronic Navigation, Inc. | 2022-06-10 | Traditional | PDF ↗ |
| K214065 | ROSA ONE Brain application | Medtech S.A.S | 2022-05-04 | Traditional | PDF ↗ |
| K214040 | ClearPoint Array System (version 1.1) | ClearPoint Neuro, Inc. | 2022-04-12 | Traditional | PDF ↗ |
| K210109 | visor2 system | Eemagine Medical Imaging Solutions GmbH | 2022-04-08 | Traditional | PDF ↗ |
| K212397 | StealthStation S8 Cranial v2.0 | Medtronic Navigation | 2021-12-22 | Traditional | PDF ↗ |
| K201435 | Molecular Flow Simulations | Therataxis, LLC | 2021-12-03 | Traditional | PDF ↗ |
| K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System | Brainlab AG | 2021-11-12 | Traditional | PDF ↗ |
| K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization | Brainlab AG | 2021-11-03 | Traditional | PDF ↗ |
| K203251 | SOLOPASS System | Intravent Medical Partners, LP | 2021-08-27 | Traditional | PDF ↗ |
| K210700 | NaviNetics D1 Stereotactic System | Navinetics, Inc. | 2021-06-17 | Traditional | PDF ↗ |
| K201752 | Disposable Pre-calibrated Suction | Brainlab AG | 2021-01-29 | Traditional | PDF ↗ |
| K202575 | ClearPoint Array System | ClearPoint Neuro, Inc. | 2021-01-22 | Traditional | PDF ↗ |
| K203639 | StealthStation Cranial Software v1.3.2 | Medtronic Navigation, Inc. | 2021-01-13 | Special | PDF ↗ |
| K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update | Brainlab AG | 2020-10-08 | Traditional | PDF ↗ |
| K201175 | StealthStation Cranial Software v1.3.0 | Medtronic Navigation, Inc. | 2020-06-03 | Special | PDF ↗ |
| K200511 | ROSA ONE Brain application | Medtech S.A | 2020-05-29 | Traditional | PDF ↗ |
| K191422 | Neural Navigator | Soterix Medical, Inc. | 2020-04-06 | Traditional | PDF ↗ |
| K200079 | ClearPoint System and Accessories | Mri Interventions, Inc. | 2020-02-13 | Special | PDF ↗ |
| K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical, Inc. | 2019-11-27 | Special | PDF ↗ |
| K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | 2019-11-01 | Traditional | PDF ↗ |
| K190250 | Microscope Navigation | Brainlab AG | 2019-09-06 | Special | PDF ↗ |
| K183276 | 7D Surgical System | 7D Surgical, Inc. | 2019-08-07 | Special | PDF ↗ |
| K190887 | Leksell Vantage Stereotactic System | Elekta Instrument AB | 2019-08-01 | Traditional | PDF ↗ |
| K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 | Medtronic Navigation, Inc. | 2019-07-31 | Traditional | PDF ↗ |
| K183325 | Modus Nav | Synaptive Medical, Inc. | 2019-07-14 | Traditional | PDF ↗ |
| K191400 | Voyager Trajectory Array Guide (V-TAG) | Mri Interventions, Inc. | 2019-06-21 | Special | PDF ↗ |
| K182417 | ROSA ONE Brain Application | Medtech S.A | 2019-02-07 | Traditional | PDF ↗ |
| K182000 | AQrate Robotic Assistance System | Globus Medical, Inc. | 2019-01-29 | Traditional | PDF ↗ |
| K181041 | 7D Surgical System Cranial Application | 7D Surgical, Inc. | 2018-08-08 | Traditional | PDF ↗ |
| K181706 | neuromate Gen III | Renishaw Mayfield Sarl | 2018-07-26 | Special | PDF ↗ |
| K180854 | Voyager Trajectory Array Guide (V-TAG) | Voyager Therapeutics, Inc. | 2018-07-23 | Traditional | PDF ↗ |
| K180206 | neuromate Gen III | Renishaw Mayfield Sarl | 2018-04-24 | Traditional | PDF ↗ |
| K172444 | ROSA BRAIN (v3.0.0.5) | Medtech S.A | 2018-03-28 | Traditional | PDF ↗ |
| K172820 | Microscope Navigation Software | Brainlab AG | 2018-03-01 | Traditional | PDF ↗ |
| K171123 | Leksell Vantage Stereotactic System | Elekta Instrument AB | 2017-09-15 | Traditional | PDF ↗ |
| K163666 | neuro inspire | Rensihaw Plc | 2017-09-15 | Traditional | PDF ↗ |
| K163209 | Fiagon Navigation System | Fiagon GmbH | 2017-09-14 | Traditional | PDF ↗ |
| K163439 | NaviENT | Claronav, Inc. | 2017-09-01 | Traditional | PDF ↗ |
| K162655 | StealthConnect Remote Viewing, Planning and Collaboration System | Medtronic Navigation, Inc. | 2017-04-21 | Traditional | PDF ↗ |
| K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | Medtronic Navigation, Inc. | 2017-03-31 | Traditional | PDF ↗ |
| K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker | Stryker Corporation | 2017-02-22 | Traditional | PDF ↗ |
| K162604 | Cranial Reducing Tubes | Medtronic Navigation, Inc. | 2016-12-30 | Traditional | PDF ↗ |
| K160811 | CRW STEREOTACTIC SYSTEM | Integra LifeSciences Corporation | 2016-12-06 | Abbreviated | PDF ↗ |
| K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016-09-14 | Traditional | PDF ↗ |
| K152764 | EXACTECH GPS | Blue Ortho | 2016-07-13 | Traditional | PDF ↗ |
| K160523 | BrightMatter Guide with BrightMatter Pointer | Synaptive Medical, Inc. | 2016-06-24 | Traditional | PDF ↗ |
| K151156 | Fiagon Navigation System | Fiagon GmbH | 2016-04-01 | Traditional | PDF ↗ |
| K153281 | BrightMatter Guide with Surface Trace Registration | Synaptive Medical, Inc. | 2016-03-30 | Traditional | PDF ↗ |
| K160434 | ClearPoint System | Mri Interventions, Inc. | 2016-03-17 | Special | PDF ↗ |
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit | Elekta Instrument AB | 2016-03-02 | Special | PDF ↗ |
| K151359 | ROSA Brain | Medtech S.A | 2015-12-18 | Traditional | PDF ↗ |
| K143420 | SYMBIS Surgical System | Imris, Inc. | 2015-10-30 | Traditional | PDF ↗ |
| K142505 | ClearPoint System | Mri Interventions, Inc. | 2015-10-21 | Traditional | PDF ↗ |
| K150301 | NavSuite3 Kit | Stryker Leibinger GmbH & Co. KG - Navigation | 2015-07-08 | Special | PDF ↗ |
| K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015-06-11 | Traditional | PDF ↗ |
| K143241 | MDT Navigable Brain Biopsy Cannula | Izi Medical Products, LLC | 2015-04-13 | Traditional | PDF ↗ |
| K142024 | BRIGHTMATTER NAVIGATION SYSTEM | Synaptive Medical, Inc. | 2015-04-02 | Traditional | PDF ↗ |
| K141833 | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION | Medtronic Navigation, Inc. | 2015-03-25 | Traditional | PDF ↗ |
| K142344 | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System | Izi Medical Products, LLC | 2015-03-20 | Traditional | PDF ↗ |
| K141559 | V-GUIDE FOR VENTRICULOSTOMIES | Arc Surgical, LLC | 2015-02-27 | Traditional | PDF ↗ |
| K140705 | NAVIGABLE BRAIN BIOPSY CANNULA SET | Izi Medical Products | 2014-12-05 | Traditional | PDF ↗ |
| K133444 | STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM | Medtronic Navigation, Inc. | 2014-07-25 | Traditional | PDF ↗ |
| K140868 | STRYKER KWIC NEEDLE | Orthovita, Inc. | 2014-06-05 | Traditional | PDF ↗ |
Product code HAW · Class II · Neurology. Data: openFDA.