510(k) K181706
- Device
- Neuromate Gen III
- Applicant
- Renishaw Mayfield Sarl
- 510(k) number
- K181706
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-26
- Date received
- 2018-06-28
- Regulation
- 882.4560
- Classification name
- Neurological Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stephane Vinot
- Address
- 31, Rue Ampere Chassieu FR 69680 69680
FDA Registration Numbers#
- 1723170
- 3010209365
- 3013176080
- 9611894
- 3008627763
- 3017210488
- 3021632375
- 3009829742
- 3027375826
- 1834331
- 9617544
- 3010047454
- 3009185973
- 1225492
- 3010462278
- 3007539489
- 3012447612
- 3005061536
- 3006405073
- 3005075696
- 2183456
- 9710332
- 8039051
- 1824206
- 3013726944
- 2182979
- 3030733800
- 3009555447
- 3010120326
- 1833920
- 3021591288
- 3008110533
- 3012322232
- 1048735
- 1226188
- 3009144915
- 3015131155
- 3015536273
- 1450662
- 3009538961
- 3006128100
- 3002808157
- 1526439
- 3048141555
- 3002250546
- 3003935342
- 2031966
- 3016438694
- 3002808022
- 1825034
- 2183671
- 3002743211
- 3013485140
- 3022310762
- 8043933
- 3023194190
- 3006783837
- 1828464
- 3043543260
- 3000270450
- 3010202439
- 3015112247
- 3014479313
- 3015207155
- 3003847101
- 9610612
- 3009050824
- 3018708317
- 1424263
- 3035366890
- 3004024955
- 3008534770
- 3012352782
- 1643264
- 3014342096
- 3009959868
- 3011050570
- 3014596751
- 8010871
- 2183570
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases