510(k) K253379
- Device
- Stealth AXiS Cranial clinical application
- Applicant
- Medtronic Navigation, Inc.
- 510(k) number
- K253379
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-26
- Date received
- 2025-09-30
- Regulation
- 882.4560
- Classification name
- Neurological Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Victoria Baldock
- Address
- 200 Medtronic Dr. Lafayette CO US 80026 80026
FDA Registration Numbers
- 3005075696
- 3006128100
- 8010379
- 1056553
- 3028006458
- 3007515069
- 2528981
- 9610612
- 1222313
- 3010197224
- 2244478
- 3013726944
- 3021008900
- 3002250546
- 3003847101
- 2133772
- 8039051
- 2183456
- 1226188
- 8010177
- 8043933
- 3027305794
- 3033536255
- 3018708317
- 3010363476
- 3008627763
- 3011874573
- 3033509898
- 3011050570
- 3008110533
- 3010047454
- 3005874553
- 3010202439
- 8030128
- 3002907620
- 2032112
- 3018094310
- 1047843
- 2011171
- 3009973505
- 3010863450
- 1043653
- 1048735
- 3023194190
- 3002808157
- 1319639
- 2182979
- 3009185973
- 3004608878
- 3012352782
- 3008868758
- 2245304
- 1928237
- 2183671
- 2434444
- 1058084
- 3002807090
- 3022232775
- 3027375826
- 1018470
- 3005216725
- 2031966
- 3017636737
- 3007014520
- 3009144915
- 3002743211
- 8043792
- 3010120148
- 1057425
- 3009538961
- 1526439
- 1836357
- 3014479313
- 3004024955
- 1818910
- 3017603615
- 3005061536
- 3009888740
- 3003761012
Source Documents
Other 510(k) Records For Product Code HAW
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026-05-01 |
| K231897 | NeuroAlign software | Medivis, Inc. | 2025-10-21 |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | 2025-09-05 |
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| 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 |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | 2024-01-12 |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | 2024-01-12 |