510(k) K231392
- Device
- NaviNetics Reusable Stereotactic System (NN1000)
- Applicant
- Navinetics, Inc.
- 510(k) number
- K231392
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-14
- Date received
- 2023-05-12
- 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
- Danielle Jondal
- Address
- 206 S Broadway Suite 700 Rochester MN US 55904 55904
FDA Registration Numbers#
- 3004016520
- 3009888740
- 1721676
- 1824206
- 8043933
- 3003955307
- 3013302242
- 3002808157
- 3010047454
- 3006639944
- 1226544
- 1721983
- 3010707607
- 2031966
- 1722447
- 3004188066
- 1834331
- 3013726944
- 3003761012
- 3006783837
- 3014479313
- 3042048690
- 1045254
- 3014251656
- 1723170
- 3010462278
- 3006846753
- 3005718816
- 3011713200
- 8010379
- 2424366
- 3009882675
- 3010009632
- 3019767615
- 3030733800
- 3009973336
- 3003477135
- 3025603301
- 3004893332
- 3011050570
- 3015536273
- 3009293341
- 3010197224
- 3009555447
- 3012447612
- 3009538961
- 1526534
- 1649518
- 3003418325
- 3002808022
- 3009050824
- 2528981
- 3010120326
- 2134947
- 2182979
- 2183456
- 3004727093
- 9610617
- 3017636737
- 9611612
- 1835572
- 1047843
- 3004464325
- 3017565094
- 9612389
- 9710332
- 3038503932
- 8010871
- 3021591288
- 3010032903
- 9610905
- 1061124
- 3008027912
- 3010120148
- 3018094310
- 8031020
- 3003847101
- 3011015572
- 3009417901
- 3010362364
Source Documents#
Other 510(k) Records For Product Code HAW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024-04-26 |