510(k) K133444
- Device
- STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
- Applicant
- MEDTRONIC NAVIGATION, INC.
- 510(k) number
- K133444
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-25
- Date received
- 2013-11-12
- 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
- KAYE WAITE
- Address
- 826 Coal Creek Cir. Louisville CO US 80027 80027
FDA Registration Numbers#
- 3003935342
- 3003847101
- 8043933
- 1625507
- 3012469182
- 3043543260
- 3010370554
- 1824206
- 3010120135
- 3004464325
- 1721676
- 3015399803
- 3011874573
- 1020279
- 9617840
- 3005061536
- 3002725845
- 3009882675
- 1219655
- 1319639
- 1835572
- 3002743211
- 3011683674
- 3008738628
- 3015536273
- 3012911444
- 3010202439
- 1928237
- 2031917
- 8030128
- 3023852420
- 2183671
- 3010362364
- 1833920
- 9612389
- 1424263
- 3004024955
- 8040537
- 3016678045
- 2434444
- 2244478
- 1226188
- 3005180920
- 3028006458
- 9610617
- 3002250546
- 3010049501
- 9610905
- 3002807090
- 3014479313
- 3009829742
- 1057425
- 3030412764
- 1721983
- 1123169
- 3000270450
- 3010120148
- 2011171
- 3003418325
- 3006697241
- 1722447
- 3018094310
- 3010822102
- 3012352782
- 3009144915
- 3016577622
- 3015232217
- 3003761012
- 3030733800
- 3005796366
- 3002808022
- 1017294
- 3048141555
- 3003998208
- 2245304
- 3007539489
- 3011050570
- 3013176080
- 3009973336
- 3010123172
Source Documents#
Other 510(k) Records For Product Code HAW #
| 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 |
Legacy Summary#
summary
FDA Review#
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