510(k) K965139
- Device
- SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
- Applicant
- CARL ZEISS, INC.
- 510(k) number
- K965139
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-23
- Date received
- 1996-12-23
- 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
- KENNETH M NICOLL
- Address
- One Zeiss Dr. Thornwood NY US 10594 10594
FDA Registration Numbers#
- 8039051
- 3005706667
- 3027305794
- 3042048690
- 3010462278
- 3010363476
- 1526439
- 1649518
- 3017004815
- 3003998208
- 2032112
- 8043933
- 3010032903
- 2424366
- 3003120897
- 3009050824
- 1226544
- 3002807090
- 1058084
- 9611612
- 2245304
- 3011713200
- 3033509898
- 3025603301
- 1319639
- 3009185973
- 3005796366
- 3006846753
- 3009959868
- 1828288
- 1045254
- 3018708317
- 3022310762
- 1836357
- 3027375826
- 3010120326
- 1721676
- 3005061536
- 3013485140
- 1526534
- 1833920
- 3010123172
- 1056553
- 3005874553
- 2183744
- 3002725845
- 3033536255
- 3006128100
- 1928237
- 9611390
- 2031093
- 1824206
- 3016050940
- 8010177
- 3006405073
- 3010120135
- 3012075008
- 3010362364
- 3014479313
- 3009973505
- 3010120104
- 3005161223
- 3004893332
- 1721983
- 1625507
- 3010209365
- 3018094310
- 3015536273
- 1225492
- 3009973336
- 3007147067
- 3003525643
- 3019767615
- 1219655
- 3015399803
- 1720929
- 3014342096
- 3015542154
- 3010120148
- 1722447
Source Documents#
Other 510(k) Records For Product Code HAW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261997 | NeuroAlign | Medivis, Inc. | 2026-10-26 |
| K262214 | Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) | Guangzhou Aimooe Technology Co., Ltd. | 2026-10-15 |
| 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 |
Legacy Summary#
summary
FDA Review#
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