510(k) K192703
- Device
- Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
- Applicant
- Brainlab AG
- 510(k) number
- K192703
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-10-08
- Date received
- 2019-09-27
- 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
- Chiara Cunico
- Address
- Olof-Palme-Str 9 Munich DE 81829 81829
FDA Registration Numbers#
- 3016577622
- 1045254
- 3005216725
- 1061124
- 8040537
- 3007539489
- 8043933
- 2031093
- 1836357
- 3006783837
- 1828464
- 1526534
- 1818910
- 3007515069
- 2528981
- 3010197224
- 3005161223
- 3015399803
- 3005075696
- 3009108888
- 1721676
- 1720929
- 3011015572
- 3012075008
- 1424263
- 3006128100
- 3003477135
- 3011713200
- 3009973336
- 9611390
- 3010707607
- 3016678045
- 3010202439
- 3002250546
- 3023194190
- 3033509898
- 3012469182
- 3003120897
- 3015877656
- 9611612
- 1825034
- 3007014520
- 1056553
- 3008114965
- 3004893332
- 3043543260
- 1037007
- 3021632375
- 9610617
- 1226188
- 2011171
- 3003790304
- 3017603615
- 1833920
- 3005796366
- 3010863450
- 3004513872
- 1625507
- 2183744
- 3010049501
- 3035366890
- 2424366
- 9611894
- 3010370554
- 3012911444
- 3030733800
- 2134470
- 3008534770
- 3003955307
- 3012447612
- 1057425
- 3017210488
- 9612389
- 3008627763
- 2245304
- 3005545216
- 3014479313
- 1824206
- 1047843
- 2183671
Source Documents#
Other 510(k) Records For Product Code HAW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026-05-01 |
| 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 |
| K233155 | ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. | 2024-01-12 |
| K233144 | ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. | 2024-01-12 |
Legacy Summary#
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FDA Review#
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