510(k) K191597
- Device
- Stealth Autoguide System, Midas Rex Legend Depth Stop System
- Applicant
- Medtronic Navigation, Inc.
- 510(k) number
- K191597
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-11-01
- Date received
- 2019-06-17
- 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
- No
Applicant Contact#
- Contact
- Jason Woehrle
- Address
- 826 Coal Creek Cir. Louisville CO US 80027 80027
FDA Registration Numbers#
- 3005677016
- 3005706667
- 3015232217
- 2245304
- 3028006458
- 3004105270
- 3020981894
- 9610617
- 3014251656
- 3011874573
- 3005796366
- 2011171
- 3010123206
- 1061124
- 3016438694
- 3030412764
- 3003761012
- 3013726944
- 3005545216
- 3003477135
- 1020279
- 1222313
- 3010041430
- 3008868758
- 3009888740
- 2134947
- 9710332
- 3006846753
- 3021591288
- 2031917
- 3011015572
- 3015453963
- 3015797559
- 1226544
- 2030624
- 3009959868
- 3014967969
- 1056553
- 3010120104
- 3015131155
- 8039051
- 2183319
- 1721983
- 3006783837
- 3009973336
- 3010049501
- 3004016520
- 3010707607
- 3005075696
- 3010209365
- 3009050824
- 2031966
- 2183744
- 3022232775
- 8031020
- 3012911444
- 3004893332
- 3011713200
- 8010871
- 8043792
- 3016577622
- 3027375826
- 3004142400
- 9612389
- 2183671
- 3007515069
- 3011724582
- 3023194190
- 1221763
- 1450662
- 3006128100
- 1625507
- 2031093
- 8030128
- 3012352782
- 3017603615
- 3021008900
- 1928237
- 3013176080
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 |
| 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 |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | 2024-01-12 |
Legacy Summary#
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FDA Review#
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