510(k) K163439
- Device
- NaviENT
- Applicant
- ClaroNav Inc.
- 510(k) number
- K163439
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-09-01
- Date received
- 2016-12-08
- 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
- Ahmad Kolahi
- Address
- 1140 Sheppard Ave. W. - Unit 10 Toronto CA M3K 2A2 M3K 2A2
FDA Registration Numbers#
- 1649518
- 3005216725
- 3018708317
- 3009970070
- 3009144915
- 3008027912
- 3005718816
- 3003525643
- 3015877656
- 3009555447
- 3043543260
- 3004188066
- 1018470
- 3006783837
- 3016678045
- 3017636737
- 3042048690
- 3004753785
- 3011713200
- 2245304
- 3009108888
- 2011171
- 3030733800
- 2183744
- 9612389
- 3030412764
- 3014170143
- 3025603301
- 3012322232
- 3033536255
- 3004727093
- 3013557562
- 3011724582
- 1824206
- 3017565094
- 2528981
- 3013485140
- 2031917
- 3023194190
- 3006697241
- 3011050570
- 3009882675
- 3004016520
- 3008738628
- 3010120135
- 1721983
- 3027375826
- 3006128100
- 2031966
- 3003120897
- 3006846753
- 3009959868
- 1225492
- 3012098629
- 3010120104
- 3015207155
- 3005677016
- 3009829742
- 8010871
- 1043653
- 3003935342
- 1928237
- 3016577622
- 1721676
- 1643264
- 3010822102
- 3019767615
- 9612277
- 3002725845
- 1020279
- 3006405073
- 1226188
- 3010707607
- 3005180920
- 3015453963
- 3010049501
- 3010462278
- 3015542154
- 3010032903
- 9710332
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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